—#70152

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K920950, K963980
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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

Timeline

Recall initiated: 2008-03-10
Posted by FDA: 2008-09-16
Terminated: 2010-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.