Recall Z-2283-2023— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-06-12. It names 2 FDA 510(k) clearances: K162859, K130638. Product: Allura Xper FD10 and FD20. X-ray Imaging System.. Reason: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-12
- Firm location
- Best, N/A, Netherlands
510(k) clearances named in this recall
2 on FDA's record- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Allura Xper FD10 and FD20. X-ray Imaging System.
Reason for recall
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.