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).
Reported: February 1, 2017 Initiated: December 1, 2016 #Z-0923-2017
Product Description
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).
Reason for Recall
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.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 1
- Distribution
- US: WA OUS: China, Spain, Korea, Republic of, Germany
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Philips Electronics North America Corporation. Units affected: 1.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-0923-2017.
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