FDAFDA · Food and drugs·Recall number Z-2716-2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Published August 28, 2024 · Recall initiated: August 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
- Lot
- Serial Numbers: 111 138 467 817 2928 269
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.