CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system recalled
Philips Medical Systems is recalling Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system, distributed in Florida. The recall was initiated on 8 Aug 2014 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-0022-2015
- FDA event ID
- 69197
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Aug 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +62 days |
| 15 Oct 2014 | 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
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Product as listed by the FDA
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Where it was distributed
US distribution to FL
Questions about this recall
Why was it recalled?
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Which lots are affected?
Model Number: Integris Allura 15-12 Serial Number: 16741023
Where was it sold?
US distribution to FL
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 26 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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