Z-0766-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236793 units in total
Product Description
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X10DF DUO - ARD568211210C, X10DF DUO - ARD568213410C, X10DF DUO - ARD568223510C, X10DF DUO - ARD568224491C, X10DF DUO - ARD568224492C, X10DF DUO - ARD568224493C, X10DF LD - ARD568213110C, X10DF LD X - ARD568223912C, X10DF LD X - ARD568223913C, X10DF V - ARD568224110C, X10DF V XD - ARD568224912C, X10DF V XS - ARD568224911C, X10DF V XS - ARD568224913C, X10LDAXL+ - ARD568213710C, X10LDAXL+ - ARD568243710C, X10SF - ARD568231110C, X10SF - ARD568244911C, X10SF DUO - ARD568231210C, X10SF DUO - ARD568233410C, X10SF DUO - ARD568243510C, X10SF DUO - ARD568244491C, X10SF DUO - ARD568244492C, X10SF DUO - ARD568244493C, X10SF LD - ARD568233110C, X10SF LD X - ARD568243911C, X10SF TRIO - ARD568244440C, X10SF V - ARD568244110C, X10VAXL+ D - ARD568224710C, X10VAXL+ D - ARD568224791C, X10VAXL+ D - ARD568224792C, X10VAXL+ SF - ARD568244710C, X10VAXL+ SF - ARD568244791C, X10VAXL+ SF - ARD568244792C
Reason for Recall
A potential for a light system to fall in the operating room.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
All systems affected