RecallRadar

FDA Device recall Z-2059-2013

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

On 2013-09-04 the FDA classified a Class II recall of Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics by Philips Healthcare, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2059-2013
ClassificationClass II
Statusterminated
Initiated2013-08-08
Published2013-09-04
Last updated2026-09-13 11:53 UTC
CompanyPhilips Healthcare
DistributionUS

Product

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

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.

Identifiers

code_info
437765/SN09000009, 452854/SN10000003, 463879/SN10000016, 500643/SN12000006,504710/SN12000011, 511454/SN12000018, 519869…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, 49

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2013%22

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