Recall Z-2928-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-06-29. It names 4 FDA 510(k) clearances: K162859, K161563, K141979 and 1 more. Product: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.. Reason: Firmware issue potentially leading to loss of geometry movements..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-29
- Firm location
- Best, Netherlands
510(k) clearances named in this recall
4 on FDA's record- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K161563 — Allura Xper FD series and Allura Xper OR Table series
- K141979 — ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
- K133292 — ALLURA XPER FD; OR TABLE
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 FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Reason for recall
Firmware issue potentially leading to loss of geometry movements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.