Recall Z-2587-2023— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-08-15. It names 4 FDA 510(k) clearances: K200917, K163715, K162859 and 1 more. Product: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems. Reason: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-15
- Firm location
- Best, Netherlands
510(k) clearances named in this recall
4 on FDA's record- K200917 — Azurion R2.1
- K163715 — Allura Xper R9
- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K050151 — MULTIDIAGNOST ELEVA
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
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Reason for recall
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Data sourced from openFDA. This site is unofficial and independent of the FDA.