Philips Allura Xper FD10 X-ray System Recalled for Loose Screws
Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where uncontrolled rotation of the C-arm poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Philips Electronics North America Corporation is recalling one unit of the Allura Xper FD10 722026 X-ray system. This device is intended for cardiovascular and vascular X-ray imaging applications, including diagnostic and interventional procedures such as PTCA, stent placement, atherectomies, pacemaker implantations, and Electro Physiology (EP).
The recall is due to a production error where screws were not tightened to the specified torque. These screws may come loose from the C-arm shaft, which could cause the C-arm to rotate in an uncontrolled manner.
The affected unit was distributed in Washington, USA, as well as in China, Spain, Korea, Republic of, and Germany. Users of this device should contact Philips for instructions on how to resolve the issue.
The recalled product
- Product
- 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).
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 783
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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