Recall Z-0015-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-09-03. It names 2 FDA 510(k) clearances: K130842, K041949. Product: Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;. Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-03
- Firm location
- Best, N/A, Netherlands
510(k) clearances named in this recall
2 on FDA's record- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K041949 — ALLURA XPER FD10
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
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Reason for recall
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Data sourced from openFDA. This site is unofficial and independent of the FDA.