CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Philips DuraDiagnost stationary X-ray system recalled
Philips Electronics North America is recalling Philips DuraDiagnost stationary X-ray system, distributed in 8 states. The recall was initiated on 17 Sep 2015 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-2682-2016
- FDA event ID
- 74685
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2015
- FDA classified
- 1 Sep 2016
- Reported
- 7 Sep 2016
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 17 Sep 2015 | Recall initiated by company | |
| 1 Sep 2016 | Classified by FDA | +350 days |
| 7 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Product as listed by the FDA
Philips DuraDiagnost stationary X-ray system
Where it was distributed
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
CaliforniaMaineNorth CarolinaNebraskaOhioOregonTexasWashington
Questions about this recall
Is Philips DuraDiagnost stationary X-ray system recalled?
Yes. Philips Electronics North America recalled Philips DuraDiagnost stationary X-ray system on 17 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-2682-2016.
Why was it recalled?
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Which lots are affected?
SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093
Where was it sold?
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
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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