Reported May 9, 2018 · Terminated
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray…
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 R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional
- fluoroscopic x-ray system Product UsageThe Allura Xper ED series is intended
- for use on human patients to performVascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
- AdditionallyThe Allura Xper ED series is compatible with a hybrid operating room
- Lot codes and dates
- Product nameAllura Xper R8.1 .25.0 Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5
- Product code
7220037220057220067220087220107220117220127220137220147220157220197220207220227220237220247220257220267220277220287220297220337220347220357220367220387322039722058722059
- Amount recalled
- 682
Where it was sold
Why it was recalled
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
This product could cause temporary or reversible health problems — stop using it.
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