Philips Medical Systems North America Co. Phillips: EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms.

Recall number

Z-2053-2008

Recalling firm

Philips Medical Systems North America Co. Phillips

Product

EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms.

Status

Terminated

Initiated

2008-03-10

Posted

2008-09-16

Terminated

2010-09-28

Reason

Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).

Root cause

Device Design

Action

On 03/14/08 the firmed mailed certified letters to the customers of the device. The letter advises of the problem and stated that images exported from the Easy Vision RAD workstation should not be used for measurements. The letter also states that the firm will be performing upgrades of the devices. If you have questions, contact Sarah Baxter at 425-487-7665 or the Philips Call Center at 800-722-9377, #5, #2.

Quantity

401 units

Distribution

Products were distributed nationwide to 159 hospitals, 3 VA's and 12 Department of Defense accounts.

Lot, serial or model codes

Part numbers and cooresponding software version in: 9896 050 03232 (SW R4 2V2L2), 9896 050 03233 (SW R4 2V2L3), 9896 050 03234 (SW R4 2V2L4), 9896 050 03235 (SW R4 2V2L5), 9896 050 03236 (SW R4 2V2L5, not delivered to the US), 9896 050 03237 (W R4 2V2L6), and 9896 050 03238 (W R4 2V2L7). The firm tracks units by Site ID and they are as follows: 540176, 540154, 534389, 534391, 521504, 521505, 521506, 521670, 521672, 521673, 521376, 534390, 521328, 521375, 521379, 104351, 104354, 104355, 104356, 104357, 521374, 521381, 534392, 534395, 104353, 534830, 534865, 535443, 535445, 535446, 546779, 540166, 521382, 540180, 540181, 540179, 504854, 102954, 102955, 102942, 105492, 505042, 505043, 534936, 86442, 520994, 520995, 521692, 521693, 521710, 521834, 522170, 104166, 519567, 533563, 102123, 532780, 103361, 531781, 533089, 533120, 533779, 533782, 533783, 533784, 533785, 533899, 534249, 506123, 506177, 506836, 506837, 505266, 541000, 541001, 105920, 105767, 505230, 104192, 104757, 104759, 104760, 104761, 104762, 105768, 505683, 531848, 531849, 531851, 531853, 537547, 102125, 102126, 102127, 506300, 506301, 506302, 506303, 506304, 531845, 531846, 536186, 102121, 105702, 533813, 105381, 105170, 105706, 105709, 506023, 506025, 506127, 519528, 104363, 105162, 105701, 250408, 519157, 520528, 520991, 520992, 530694, 105383, 105398, 105400, 105401, 105698, 505489, 519837, 87167, 105697, 105710, 105711, 105712, 105782, 105907, 505842, 505843, 505844, 534167, 536167, 539032, 105632, 521453, 535448, 521454, 521937, 521938, 105168, 105172, 536086, 536593, 536595, 102643, 105384, 104350, 105161, 105163, 105175, 250063, 250077, 250078, 519572, 520164, 520671, 522174, 522176, 534383, 542527, 506399, 506400, 506551, 506552, 519840, 522259, 105166, 522262, 105936, 535449, 103978, 103979, 104011, 105320, 520684, 521674, 532073, 532108, 532109, 534384, 104053, 104006, 504357, 103326, 103567, 104362, 505121, 505128, 505133, 506204, 519806, 519885, 520047, 521006, 522256, 531850, 83034, 83035, 83036, 86029, 86030, 86239, 86240, 87150, 87151, 87152, 87166, 100920, 100922, 100923, 100956, 101306, 101646, 101696, 101698, 101892, 102029, 102145, 102146, 102147, 102644, 102831, 102832, 102906, 103042, 103177, 103205, 103226, 103294, 103339, 103565, 103578, 103706, 103715, 103810, 103822, 103824, 103825, 103853, 103914, 103918, 103940, 103973, 103974, 104031, 104092, 104344, 104352, 104522, 104524, 104525, 104527, 104538, 104582, 104583, 104633, 104677, 104790, 104970, 105164, 105171, 105173, 105192, 105231, 105321, 105354, 105669, 105704, 105893, 105962, 504740, 504880, 504881, 505004, 505051, 505092, 505122, 505123, 505124, 505126, 505127, 505129, 505130, 505131, 505132, 505667, 505889, 506154, 506294, 506351, 506352, 506395, 506444, 506472, 506780, 506847, 506849, 519108, 519109, 519110, 519111, 519112, 519123, 519647, 519876, 519877, 519878, 519882, 519884, 520243, 520407, 520408, 520672, 520673, 520683, 520685, 520686, 520704, 520757, 520763, 520767, 520771, 520782, 520786, 520788, 520789, 520790, 520796, 520797, 520931, 520962, 520963, 520970, 520972, 521052, 521112, 521230, 521447, 521517, 521519, 521746, 521827, 521865, 521891, 521963, 522175, 522196, 522217, 522246, 522252, 522371, 522460, 522474, 530402, 530414, 530561, 530563, 530606, 530627, 530674, 530758, 531831, 532071, 532270, 532276, 532277, 532475, 532476, 532784, 533241, 533247, 533321, 533529, 533561, 534379, 534381, 534407, 534430, 534601, 534626, 535410, 535442, 535679, 536615, 537529, 539244, 539371, 539937, 541901, 542525, 543598, X1776

510(k) numbers

["K920950","K963980"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

1000524572

Firm city

Bothell

Firm state

WA

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

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