Recall Z-1159-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I · Ongoing
Class I FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-01-13. It names 5 FDA 510(k) clearances: K200917, K172822, K163715 and 2 more. Product: Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).. Reason: Possibility of the patient falling from the table related to the mattress used on the patient table..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-01-13
- Firm location
- Best, N/A, Netherlands
510(k) clearances named in this recall
5 on FDA's record- K200917 — Azurion R2.1
- K172822 — Azurion series R1.2
- K163715 — Allura Xper R9
- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K033737 — ALLURA XPER FD20
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
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Reason for recall
Possibility of the patient falling from the table related to the mattress used on the patient table.
Data sourced from openFDA. This site is unofficial and independent of the FDA.