Philips North America: CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

Recall number

Z-1387-2024

Recalling firm

Philips North America

Product

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

Status

Open, Classified

Initiated

2024-02-28

Posted

2024-03-27

Terminated

not on file

Reason

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

Root cause

Under Investigation by firm

Action

An URGENT Medical Device Correction dated 2/27/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 1. The Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status. 2. Customers should update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affecting the annunciation of custom ringtones. 3. Customers should complete the Urgent Medical Device Correction Response Form at the end of the notification to submit both their acknowledgement of this recall and confirm understanding of actions to be taken. 4. This communication should be shared with all clinical staff to review and understand. 5. Place this Urgent Medical Device Correction notification with the documentation of the Care Event and Patient Information Center iX (PlC ix) Revision 4. For Distributors: Philips is requesting customers to return a Response Form to acknowledge receipt and understanding of the Medical Device Correction and confirm that the information from this Letter has been properly distributed to all users that handle the affected product. Together with this letter we are providing a list of affected products that Philips has sold to your organization. As distributor of the affected products, we kindly request that you: Send the attached Medical Device Correction to each customer to whom you have distributed any affected product as soon as possible and no later than? days, together with the Reply Card. Perform a good faith effort to ensure Notification and Reply Form arc deliver to the customer with a minimum of three attempts, and if possible, using multiple contact methods. Actions planned by Philips to correct the problem 1, The action by Philips

Quantity

2,323 Units

Distribution

Worldwide - US Nationwide distribution.

Lot, serial or model codes

UDI-DI: (01)00884838099128(10)C.03.00; Serial Numbers: 5T6W-21KC-4 3L0R-7AHH-C 1F1G-01JC-6 415A-26K6-9 605K-5AGH-2 5J5G-0ZNF-4 7A6D-4TL3-Y 233Z-0LJ3-C 142W-3VM1-3 1863-19MD-E 3F0T-7AHH-C 4R5K-5AGH-W 2T5M-55J9-W 0U6Z-70HU-B 795Z-7FHX-E 2K3W-3PJ8-0 3T5Z-7FHX-2 0B13-0MNA-8 0R0E-63JK-C 644J-1CJJ-1 470D-63JK-A 2022-0XNW-V 5W2A-5MGJ-D 0141-2RHR-B 6944-5RM5-A 7G7Y-76MW-C 0L09-3WPK-J 2R1E-50P2-3 3967-33KR-R 3H3M-28MC-X 4E1V-5LH0-8 5Y57-68PX-9 150B-02P6-L 3W5D-7UMF-J 0C33-3MMP-U 181U-7TJA-2 2V6Z-1ZL8-C 2468-33KR-T 0J1J-1KG1-4 591H-1KG1-9 194W-72P0-E 2Y57-6TKK-D 2W0U-6WNX-P 7L3W-3PJ8-R 2044-77KZ-8 2G1U-7TJA-9 6E7C-1XPT-M 7L0M-4AH2-1 0U41-6BK3-L 6G5N-4LGG-3 232E-2FMY-X 6R22-07LZ-R 1P5K-5AGH-2 2378-6CPV-2 0550-53NK-T 0F13-59N8-K 1M4Y-78J7-0 0B5Z-7FHX-F 4C04-4ZPR-E 0V6H-7PGV-K 4T3C-1AHM-K 4673-5WKF-5 1F6P-0PLF-T 4F0B-02P6-K 5327-0CKW-L 023M-4WMG-F 490H-6AMX-8 007P-5FNJ-Y 696N-3KLU-H 4Z71-6UGD-L 622C-0NNG-A 4D2U-1VNP-J 5P2P-79HL-W 4B22-07LZ-1 6T6P-0PLF-N 1D7K-0VKT-M 2C5V-11KG-5 6H2D-2FMY-Y 4468-7VM6-B 1F40-2RHR-F 5857-68PX-B 0V4U-45K5-4 5D2H-15LB-L 6F01-38KA-0 6W2M-1RHT-G 0816-5DJ6-5 0U2P-0WPA-U 0D7G-0BLD-N 7B7Y-2CJW-7 0372-6UGD-X 1F0H-23HD-C 3E3T-7KGB-Y 4Z6T-5ZH1-2 176C-3BNE-4 042E-2FMY-W 0X26-14LG-J 4152-30PD-X 6A40-2RHR-T 3C02-71KX-X 657A-49M4-C 0V3W-3PJ8-A 1T6X-1UP5-6 0F4U-57JE-Z 041G-01JC-8 621E-50P2-1 1C67-5XN6-8 686B-7VM6-G 5X4B-40KU-2 3K1U-7TJA-Z 6320-1DNN-P 2H3U-6YM2-V 4Z2W-3VM1-F 1T7E-2UGW-Z 4N03-5TLL-9 2W3V-3PJ8-L 0E08-3WPK-K 3W1U-7TJA-4 7Y6B-2ZKV-9 2B1V-48PE-N 1327-0CKW-R 6A0A-64MU-1 2C7U-4VK7-C 2A5E-5VMH-H 3Z15-4JK4-P 0N24-4YL5-9 4C58-6TKK-J 3R18-5DJ6-L 0607-4DL4-0 5N1E-50P2-6 2V22-07LZ-K 0923-4YL5-Z 1678-09GU-P 4H48-7GN2-R 1A6R-0PLF-T 6K3J-5PP3-0 2D5V-2PJT-M 6K66-4PJB-1 4M2A-5MGJ-3 7A7A-49M4-W 2405-6RJX-J 4V31-5BNT-0 021E-42GL-M 2A00-2CJW-G 110X-3GJ0-Y 3U73-5WKF-A 7Y4K-7WMK-T 7C53-30PD-A 0X61-5UGY-D 2K0X-0TLA-F 3X3X-7ZPB-A 075K-0JLM-J 0P7L-7MPL-F 0R7M-0VKT-P 0U04-4ZPR-8 155C-6JK9-3 1F67-4PJB-3 2D5Z-7FHX-7 2P17-4JK4-J 393L-6VGP-7 3A3B-13JG-V 3K2F-2FMY-X 4K3E-41PZ-K 522M-47P7-Z 5707-4RG3-J 6L6D-4TL3-1 7A2E-0NNG-K 1H45-7ELE-8 203A-13JG-9 3Y39-16GM-Z 6P54-2END-1 6X5H-0ZNF-K 783Y-7ZPB-N 790U-6WNX-B 7Z7Y-2CJW-B 0547-7GN2-F 0A28-6MKH-5 0D5Y-7FHX-R 0M4R-37N1-6 0R1L-18LJ-A 1B2F-15LB-W 1K7A-49M4-7 1R1A-0ALR-U 200L-4FL0-P 235N-4LGG-E 2815-5DJ6-J 2B43-5RM5-P 2F6V-21KC-L 2M16-1MHK-0 2M5J-5AGH-N 3Z3Y-7ZPB-M 460L-6GLT-K 4A7V-7BG9-9 4K6B-2ZKV-D 4U1N-75JN-D 5F3P-67ME-J 5K0H-23HD-W 5P7F-0BLD-2 5W1F-01JC-A 6W65-7XLV-W 7D7Z-76MW-6 7R31-24GX-L 2J40-6BK3-T 4W5N-4LGG-1 0B1N-4HGE-M 0C5N-4LGG-M 0N70-1ZL8-5 0W3U-6ZJ1-F 1D2L-2TP9-3 1E0T-7AHH-H 1J0D-69LP-8 1K0L-4FL0-Z 1K2K-47P7-E 1T5L-55J9-C 2P0Y-6FKB-G 313C-1AHM-W 3721-0XNW-L 454V-45K5-K 4B3T-7KGB-6 5955-58M8-C 6058-6TKK-L 6212-4GJY-9 6B2K-47P7-1 6Y7W-4VK7-L 720X-0TLA-X 745F-0ZNF-V 7P1X-48PE-F 1828-6MKH-A 0M18-2JPY-V 1H22-36KM-9 1X26-5CKL-2 286H-7PGV-A 3G1U-22HW-T 3M01-76MW-K 474Y-5JHY-T 4A35-3ALK-J 5051-53NK-L 6T6R-0DN4-6 752N-79HL-Z 7749-4XM7-L 797B-49M4-G 000Z-2DMM-A 005C-6JK9-K 0257-68PX-2 060G-4MHC-L 0777-27LY-G 0812-4BPG-Z 0908-4DL4-8 0C6V-6XMZ-E 0G64-74NU-D 0J4X-7RPJ-D 0L61-5UGY-8 0M50-78J7-U 0V5P-0YG8-V 0W4Z-78J7-X 0X4M-2BNM-N 0Y1J-1KG1-0 0Z3N-4NPW-T 1070-70HU-0 165X-2VNH-X 177U-56K0-D 183W-6ZJ1-C 1F3V-6ZJ1-6 1J72-2NL7-T 1L4B-2HJF-U 1L4G-0EG2-Z 1L74-3ZKP-E 1P0L-4FL0-K 1U5M-5AGH-V 1Z07-0UH7-3 1Z7H-06MT-4 1Z7K-7MPL-5 2253-30PD-D 250G-60JV-W 2809-3WPK-L 287W-7BG9-2 2B0L-4FL0-N 2D5L-73HZ-E 2N0V-6WNX-U 2N70-70HU-X 2N7X-00G0-U 2P5N-4LGG-J 2Y3J-6VGP-7 2Y4G-1GL2-Z 2Z37-04K8-6 303G-0KN0-X 3046-12JD-7 3245-54M3-H 326C-1PJ5-4 3326-0CKW-5 365R-0YG8-8 3A6N-3KLU-H 3D42-6BK3-9 3E20-0XNW-E 3H7H-0BLD-R 3L2C-6DHP-L 3L5H-0JLM-6 3N4Y-72P0-7 3N61-5UGY-Z 3P10-2GGN-B 3V3G-4UJL-D 3V7U-5KGZ-6 4036-04K8-G 407T-5KGZ-5 430T-3TLN-4 4356-68PX-A 4L6G-3DKJ-B 4N7P-5FNJ-R 4U7W-31N5-6 4V7U-31N5-1 4Z1H-01JC-4 514E-34MB-9 533E-41PZ-2 542B-5MGJ-6 5565-19MD-M 560U-6WNX-N 5E19-2JPY-W 5G3R-67ME-0 5L29-6MKH-K 5L7L-0VKT-D 5N22-07LZ-Z 5P4E-0EG2-G 5U02-1FHE-2 6161-5UGY-V 624M-03P1-U 633E-0KN0-F 642P-79HL-L 6644-77KZ-J 674V-45K5-B 687U-4VK7-L 6C0V-08NR-V 6C37-4KHG-Y 6D7C-62PF-J 6E65-7XLV-6 6E6W-21KC-4 6G55-58M8-N 6R4M-2BNM-Z 6X0C-3EH3-G 6X0R-17M9-3 706W-21KC-D 711C-0ALR-V 726K-0RGF-5 741T-22HW-8 750D-3EH3-8 7557-0HN3-J 756U-6XMZ-B 760T-6WNX-3 7836-04K8-M 7940-2RHR-V 7F1F-7HJU-4 7F4M-43JR-8 7F4X-45K5-L 7K1U-22HW-C 7L5N-4LGG-N 7N6U-6XMZ-R 7V04-5TLL-8 7V2V-05HF-W 7V62-5UGY-X 0774-3ZKP-N 1V15-5DJ6-U 235L-73HZ-C 3Z4F-34MB-2 4608-4DL4-D 512A-5MGJ-Y 5N5P-0YG8-5 6V06-4RG3-4 741Z-1WJ2-R 0L3K-6VGP-R 1F1B-0ALR-6 2C5E-5VMH-B 3C7A-49M4-U 6J07-4RG3-G 6P61-5UGY-T 6R6K-0RGF-4 7B3W-3PJ8-K 0K2M-1RHT-H 1H6G-1JPH-D 1Y3R-67ME-U 2C1K-1KG1-5 2H75-3ZKP-7 4004-5TLL-W 5L5K-0JLM-6 744N-03P1-4 7Z1F-50P2-U 5L16-5DJ6-W 6R6U-52P8-6 0375-27LY-U 0931-5BNT-U 0A4A-44NB-3 0U56-68PX-9 0V6Z-70HU-8 0W5J-10GT-T 1235-3ALK-D 137C-4EJH-2 152J-47P7-7 1A7H-7LPC-Z 1J73-2NL7-A 1T6W-52P8-A 2B38-4KHG-N 2G2K-47P7-N 3605-5TLL-W 387B-49M4-P 3B72-6UGD-2 3F5Z-32PN-J 483D-41PZ-3 4E3U-7KGB-E 4G0A-64MU-H 4J1D-42GL-G 4L4Y-5JHY-J 4N4W-7RPJ-C 4N68-33KR-1 4U1J-1KG1-8 522N-79HL-A 5955-68PX-6 595X-32PN-0 5B7G-2UGW-7 5F2J-6LPP-Y 5L33-61K2-V 5M7N-2AGC-F 5N36-3ALK-Y 5P4U-5GPU-C 614P-37N1-B 624D-40KU-L 6330-3RLW-5 6H72-6UGD-D 717L-7MPL-A 774G-1GL2-Z 7A29-0CKW-Z 7B0H-23HD-J 7T2Z-65P4-X 7U0D-69LP-A 7W2F-7YK1-Z 7W46-54M3-G 150E-63JK-4 3X1H-5NMA-2 5F43-6BK3-J 3F73-5WKF-B 641X-2MNL-9 047L-0VKT-2 073E-0KN0-9 074Y-5JHY-X 321K-5NMA-M 3A6H-7PGV-3 5958-0HN3-T 6H2Y-65P4-5 086V-52P8-D 0V29-6MKH-3 1R2N-79HL-C 1U2B-5YJP-8 4T0A-64MU-N 5R0V-08NR-R 7T4A-2HJF-L 101T-7TJA-9 7E5T-66H9-D 2C47-7GN2-R 2K6H-3HL1-1 2M71-6UGD-L 4818-4CLX-Y 5U7F-0BLD-T 5Y1M-1TLH-W 6K48-7GN2-G 6P35-3ALK-9 7F0V-6FKB-G 064Y-78J7-E 0M74-3ZKP-C 0U4A-4XM7-K 0Y6E-39G4-4 1B6E-39G4-W 1F2W-7DL9-D 1M47-7GN2-Y 1M5L-55J9-R 1M74-3ZKP-B 1N5H-0ZNF-D 2710-2GGN-W 2C0G-60JV-7 2F5N-4LGG-A 2T15-59N8-M 2U4V-45K5-N 313P-51MJ-V 354G-34MB-1 3B6K-3NNV-D 3N45-77KZ-N 3N4G-1GL2-N 460E-4MHC-E 4615-4JK4-1 4J0Z-2GGN-H 4R16-5DJ6-H 4W2L-47P7-1 512V-3VM1-P 5D5A-1NH8-Z 5W0A-64MU-C 5Z7M-7JG6-7 611V-22HW-L 6511-2GGN-F 651G-7HJU-L 676F-39G4-L 6A5H-10GT-R 6E0E-63JK-4 6W4D-0EG2-F 6Z31-24GX-0 785K-73HZ-7 7B4G-0GN9-9 7N7K-7LPC-P 5B1T-6PKN-C 1P3M-4WMG-F 125Z-7FHX-9 143A-13JG-Y 0E0E-63JK-A 0F10-2GGN-6 0N7K-7CNC-Z 0R1M-4HGE-X 0T4J-0GN9-8 0U14-59N8-3 0W64-5EHN-E 0Y2J-47P7-X 153X-3UN7-N 180D-69LP-6 1964-5EHN-6 2R3K-6VGP-A 392A-5MGJ-8 3L1J-1KG1-V 4426-14LG-T 4T1X-3CH6-9 5259-6TKK-0 5C7L-0VKT-5 5M4Z-6KKD-J 5Z4R-2LKY-7 6A6D-4TL3-Z 6T18-4CLX-9 6V5D-7UMF-J 735A-26K6-0 7N7D-62PF-7 7V0B-3WPK-R 7W5X-2VNH-M 2U0H-23HD-A 136H-7PGV-U 6F1L-1TLH-P 574R-37N1-B 1X0H-23HD-2 604G-1GL2-M 7F2Y-65P4-A 1H3G-41PZ-Y

510(k) numbers

["K161164"]

PMA numbers

not on file

Product code

MSX

Firm FEI

3006648320

Firm city

Cambridge

Firm state

MA

Firm country

not on file

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