Reported Feb 1, 2017 · Terminated
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Allura Xper FD20 R8.2 722028
- is intended forCardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP)
- Lot codes and dates
- 1000
- Amount recalled
- 2
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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