FDAFDA · Food and drugs·Recall number Z-0924-2017
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Published February 1, 2017 · Recall initiated: December 1, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- US: WA OUS: China, Spain, Korea, Republic of, Germany
- Lot
- 1000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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