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U.S. Department of Health and Human Services

Class 2 Device Recall EasyVision RAD

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 Class 2 Device Recall EasyVision RADsee related information
Date Initiated by FirmMarch 10, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on September 28, 2010
Recall NumberZ-2053-2008
Recall Event ID 47775
510(K)NumberK920950 K963980 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductEasyVision 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.
Code Information 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
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall
Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).
FDA Determined
Cause 2
Device Design
ActionOn 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 in Commerce401 units
DistributionProducts were distributed nationwide to 159 hospitals, 3 VA's and 12 Department of Defense accounts.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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