—#120999

Product

Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K982795
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-08-08
Posted by FDA: 2013-08-26
Terminated: 2020-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.