PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 72…
- Recall date
- August 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2716-2024
- FDA classification
- Class II
- Brand / firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Sold / distributed
- Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Why it was recalled
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
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