Reported Sep 4, 2013 · Terminated

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

Philips Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810

Is this the product you have?

Philips Easy Upgrade DR
Code No712086 This system is used for making X-Ray exposures for diagnostics

Lot codes and dates: 90 of 90 codes
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
Amount recalled: 89

Where it was sold

Nationwide
AZ
CA
CO
DE
FL
GA
MO
MS
NC
NH
NY
PA
TX

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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Philips Healthcare Inc.

Mobile Diagnostic X-Ray System with Digital Panel Apr 12, 2017
Philips IntellVue Info Center iX 866023 Jun 18, 2014
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System… Aug 28, 2013
Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 &… Jul 31, 2013
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052… Jun 26, 2013
HeartStart MRx Monitor/Defribillator May 8, 2013

27 in total.

Where it was distributed

All recall categories · Browse the whole archive