—#204162

Product

Zenition 50 & 70 Mobile Surgery C-arm

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183040, K183101, K212813
Affected lot / code info: Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824

Why it was recalled

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Root cause (FDA determination)

Device Design

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: United States Territories of Puerto Rico, Guam, and Virgin Islands

Timeline

Recall initiated: 2023-10-04
Posted by FDA: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.