Recall Z-1077-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-01-13. It names 3 FDA 510(k) clearances: K162859, K041949, K031333. Product: Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026. Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-13
- Firm location
- Best, Netherlands
510(k) clearances named in this recall
3 on FDA's record- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K041949 — ALLURA XPER FD10
- K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
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 Catalog (1) 722003 (2) 722010 (3)722026
Reason for recall
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Data sourced from openFDA. This site is unofficial and independent of the FDA.