CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Allura Xper FD10 722026 is intended for: Cardiovascular recalled
Philips Electronics North America is recalling Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging, distributed in Washington. The recall was initiated on 1 Dec 2016 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-0923-2017
- FDA event ID
- 75845
- Recalling firm
- Philips Electronics North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2016
- FDA classified
- 20 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 1 Dec 2016 | Recall initiated by company | |
| 20 Jan 2017 | Classified by FDA | +50 days |
| 1 Feb 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
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Product as listed by the FDA
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Where it was distributed
US: WA OUS: China, Spain, Korea, Republic of, Germany
Questions about this recall
Why was it recalled?
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Which lots are affected?
783
Where was it sold?
US: WA OUS: China, Spain, Korea, Republic of, Germany
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.
Other products in this recall event
3 other products · FDA event 75845This product is part of a recall event; the main page for the event is Allura Xper FD20 R8.2 722028 is intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Allura Xper FD20 R8.2 722028 is intended recalled | Philips Electronics North America | Other | WA | |
| CLASS II | Allura Xper FD20/15 R8.2 722058 is intended recalled | Philips Electronics North America | Other | WA | |
| CLASS II | Allura Xper FD20 722012 is intended for: Cardiovascular recalled | Philips Electronics North America | Other | WA |
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