Reported Oct 31, 2018 · Terminated

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031,…

Philips Medical Systems GmbH, DMC

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 Medical Systems Gmbh, DMC · Development And Manufacturing Ctr. · Hamburg, N/A · N/A

Is this the product you have?

  • Philips DigitalDiagnost software 4.1.x and 4.2.x
  • A Stationary X-ray System Models
    • 712027
    • 712028
    • 712029
    • 712031
    • 712032701032
    • 712033
    • 712224
    • 712225
    • 712226
    • 712227
    • 712228
Lot codes and dates
  • Software 4.1.x and 4.2
  • x Serial Numbers

    105 of 105 codes

    • 547772/SN14000040
    • 549865/SN14000071
    • SN14000090
    • 554080/SN15000110
    • SN15000165
    • SN15000174
    • SN15000173
    • SN15000180
    • SN15000189
    • SN15000190
    • SN15000192
    • SN15000196
    • SN15000225
    • SN15000264
    • SN15000281
    • SN15000283
    • SN15000282
    • SN15000288
    • SN15000291
    • SN15000298
    • SN15000304
    • SN15000303
    • SN15000327
    • SN15000153
    • SN15000152
    • SN15000350
    • 563654/SN15000364
    • SN15000355
    • SN15000364
    • SN15000371
    • SN15000372
    • SN15000374
    • SN15000373
    • SN15000379
    • SN15000433
    • SN15000443
    • SN15000442
    • SN15000444
    • SN15000449
    • SN16000008
    • SN16000023
    • SN16000025
    • SN16000037
    • SN16000043
    • SN16000050
    • SN16000063
    • SN16000073
    • SN16000095
    • SN16000092
    • SN16000105
    • SN16000104
    • SN16000113
    • SN16000112
    • SN16000123
    • SN16000124
    • SN16000137
    • SN16000143
    • SN16000142
    • SN15000211
    • SN16000146
    61

    722 of 722 codes

    • SN16000465
    • SN17000024
    • SN17000027
    • SN17000034
    • SN17000038
    • SN17000044
    • SN17000045
    • SN17000058
    • SN17000070
    • SN17000084
    • SN17000090
    • SN17000092
    • SN17000100
    • SN17000107
    • SN17000106
    • SN17000114
    • SN17000126
    • SN17000127
    • SN17000141
    • SN17000151
    • SN17000150
    • SN17000166
    • SN17000171
    • SN17000185
    • SN17000190
    • SN17000147
    • SN17000160
    • SN17000216
    • SN17000217
    • SN17000231
    • SN17000235
    • SN17000263
    • SN17000264
    • SN17000262
    • SN17000278
    • SN17000283
    • SN17000289
    • SN17000288
    • SN17000294
    • SN17000295
    • SN17000311
    • SN17000305
    • SN17000317
    • SN17000326
    • SN17000329
    • SN17000335
    • SN17000303
    • SN17000334
    • SN17000342
    • SN17000346
    • SN17000349
    • SN17000352
    • SN17000351
    • SN17000359
    • SN17000362
    • SN17000376
    • SN17000373
    • SN17000372
    • SN17000395
    • SN17000399
Amount recalled
829 units

Where it was sold

  • Nationwide

Why it was recalled

Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline

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

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 10, 2023 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.