FDAFDA · Alimentos y medicamentos·N.º oficial Z-2059-2013
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Publicado el 4 de septiembre de 2013 · Inicio del retiro: 8 de agosto de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Healthcare Inc.
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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