Reported Mar 16, 2016 · Terminated
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended…
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?
- Philips X-Ray Systems, Allura Xper with R8.2.16
- Product UsageThe Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10
- and Allura Xper FD2O/20 is intended for Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures
- Lot codes and dates
- Product Codes
722026722027722028722029722033722034722035722036722038722039722058722059 systems with release R8.2.16
- Product Codes
- Amount recalled
- 196 devices
Where it was sold
Why it was recalled
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
This product could cause temporary or reversible health problems — stop using it.
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