CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Philips DigitalDiagnost 1.x X-Ray System recalled
Philips Electronics North America is recalling Philips DigitalDiagnost 1.x X-Ray System, distributed nationwide in the US. The recall was initiated on 11 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2154-2017
- FDA event ID
- 77312
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2017
- FDA classified
- 9 Jun 2017
- Reported
- 21 Jun 2017
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 11 May 2017 | Recall initiated by company | |
| 9 Jun 2017 | Classified by FDA | +29 days |
| 21 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
Product as listed by the FDA
Philips DigitalDiagnost 3.1.x X-Ray System
Where it was distributed
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Nationwide ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriNorth Carolina
Questions about this recall
Is Philips DigitalDiagnost 1.x X-Ray System recalled?
Yes. Philips Electronics North America recalled Philips DigitalDiagnost 1.x X-Ray System on 11 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2154-2017.
Why was it recalled?
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
Which lots are affected?
DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
Where was it sold?
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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