Zenition 50 & 70 Mobile Surgery C-arm
- Company
- Philips North America
- Recall Initiated
- October 4, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-0226-2024
- Firm Location
- Cambridge, MA
Reason for Recall
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.
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
Lot / Code Info
Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824
Root Cause
Device Design
More recalls by Philips North America
Ingenia Elition S.
Product Code (REF): (1) 781357, (2) 782106, (3)782137.
MR systems with SW versi...
Jan 29, 2026
SmartPath to dStream for 3.0T.
Product Code (REF): 782145.
MR systems with SW version R11.1 and R1...
Jan 29, 2026
Ingenia 3.0T CX.
Product Code (REF): 781271.
MR systems with SW version R11.1 and R12.1.
Jan 29, 2026