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U.S. Department of Health and Human Services

Class 2 Device Recall Radiographic system, digital

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  Class 2 Device Recall Radiographic system, digital see related information
Date Initiated by Firm August 08, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on September 03, 2020
Recall Number Z-2059-2013
Recall Event ID 65950
510(K)Number K982795  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips Easy Upgrade DR, Code No: 712086

This system is used for making X-Ray exposures for diagnostics.
Code Information 437765/SN09000009, 452854/SN10000003, 463879/SN10000016, 500643/SN12000006,504710/SN12000011, 511454/SN12000018, 519869/SN13000005, 524432/SN13000007, 500643/SN12000006, 436570/SN09000008, 511492/SN12000019, SN09020039, SN09010077,  438946/SN09000011, SN10002064, SN11020126, SN12020282, 516048/SN12000021, SN13020163, 524411/SN13000011, 409205/SN08000002, 438474/SN09000040, 448425/SN10000001, 449743/SN10000010, 461559/SN10000014, 493489/SN11000008, 496231/SN12000003, 434381/SN09000005, 456026/SN10000011, 465845/SN11000005, 471608/SN11000001, 481912/SN11000004, 508150/SN12000015, 524367/SN13000009, 524510/SN13000010, SN07020246, 485916/SN11000007, 428148/SN09000006, 423585/SN09000003, 500351/SN12000009, 506215/SN12000012, 520201/SN13000003, 409442/SN08000003, 419279/SN09000001, 518054/SN13000001, 460532/SN10000013, SN09020304, 443304/SN09000012, 443310/SN09000013, 416734/SN08000005, 420531/SN09000002, 423195/SN09000004, 460544/SN10000017, 454997/SN10000009, 496323/SN12000002, 496324/SN12000001, 399965/SN08000001, 438232/SN09000010, SN09020302, 443840/SN09000014, 452406/SN10000004, 454310/SN10000005, 478444/SN11000003, 502350/SN12000007, 502355/SN12000016, 520759/SN13000006, 434429/SN09000007, 451666/SN10000002, 453781/SN10000008, 453960/SN10000007, 459266/SN10000012, 460755/SN10000015,  466174/SN10000019, 468076/SN10000020, 471702/SN11000002, 499486/SN12000004, 501950/SN12000008, 503132/SN12000010, 507693/SN12000013, 507694/SN12000014, 519994/SN13000004, 520759/SN13000006,SN09001033, SN09020312, SN09000826, SN11000761, 493873/SN11000009, SN12020117, SN12020322, SN12020440 
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare sent an Urgent Field Safety Notice letter dated July 24, 2013, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed : When reading an image, a physician should not use the mirror icon for image side interpretation. 2. Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of patient or equivalent electronic markers to provide Left/Right indications, during all X-ray image acquisitions. Philips will upgrade the system, which involves software and hardware upgrades of the system. The software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system (including an addendum). If you need any further information or support concerning this, please contact your local Philips representative Technical Support Line at 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.
Quantity in Commerce 89
Distribution Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA and TX., and the countries of Canada, Australia, China, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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