PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

Recall number

Z-1926-2024

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

Status

Open, Classified

Initiated

2024-05-02

Posted

2024-05-30

Terminated

not on file

Reason

Potential for pressure wave data synchronization from two devices may not be correct.

Root cause

Component design/selection

Action

Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization procedure in accordance with Section 6.9 of the IFU for the Philips Hemodynamic Application. Consignees are to complete and return the provided response form within 30 days of receipt. Customers with any questions are to contact Philips Customer Care Solutions Center at 1-800-722-9377. Philips will install a software update to correct this issue and will contact consignees to schedule the onsite visit to perform the upgrade.

Quantity

391 units

Distribution

Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.

Lot, serial or model codes

Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, (01)00884838101180(21)2111600887, (01)00884838101180(21)629, (01)00884838101180(21)2111600641, (01)00884838101180(21)2111601079, (01)00884838101180(21)2111601443, (01)00884838101180(21)2111601444, (01)00884838101180(21)1104, (01)00884838101180(21)1133, (01)00884838101180(21)812, (01)00884838101180(21)2111601067, (01)00884838101180(21)571, (01)00884838101180(21)2111600465, (01)00884838101180(21)2111600628, (01)00884838101180(21)2111600809, (01)00884838101180(21)1195, (01)00884838101180(21)2111601172, (01)00884838101180(21)2111601176, (01)00884838101180(21)168, (01)00884838101180(21)2111600797, (01)00884838101180(21)2111600664, (01)00884838101180(21)195, (01)00884838101180(21)196, (01)00884838101180(21)780, (01)00884838101180(21)781, (01)00884838101180(21)69, (01)00884838101180(21)2111600764, (01)00884838101180(21)2111601312, (01)00884838101180(21)2111600814, (01)00884838101180(21)42, (01)00884838101180(21)129, (01)00884838101180(21)130, (01)00884838101180(21)2111600936, (01)00884838101180(21)2111600794, (01)00884838101180(21)105, (01)00884838101180(21)2111601478, (01)00884838101180(21)2111600759, (01)00884838101180(21)2111601677, (01)00884838101180(21)2111601338, (01)00884838101180(21)496, (01)00884838101180(21)1155, (01)00884838101180(21)1156, (01)00884838101180(21)2111601612, (01)00884838101180(21)2111601613, (01)00884838101180(21)65, (01)00884838101180(21)62, (01)00884838101180(21)2111601229, (01)00884838101180(21)480, (01)00884838101180(21)983, (01)00884838101180(21)206, (01)00884838101180(21)1151, (01)00884838101180(21)2111600934, (01)00884838101180(21)187, (01)00884838101180(21)2111601628, (01)00884838101180(21)448, (01)00884838101180(21)831, (01)00884838101180(21)832, (01)00884838101180(21)833, (01)00884838101180(21)2111601039, (01)00884838101180(21)970, (01)00884838101180(21)971, (01)00884838101180(21)972, (01)00884838101180(21)973, (01)00884838101180(21)2111601409, (01)00884838101180(21)2111601464, (01)00884838101180(21)2111601357, (01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, (01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037 (01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.

510(k) numbers

["K181311"]

PMA numbers

not on file

Product code

MWI

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy