Device product
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Z-2059-2013
Product summary
- Event
- Event 65950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89
- Official record key
device-enforcement:Z-2059-2013
Official wording
Reason: 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.
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
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.
Derived failure modes
-
Unknown
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.