Recall Z-0766-2024— Getinge Usa Sales Inc

Name: FDA recall Z-0766-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-08

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-11-08. It names one FDA 510(k) clearance: K040735. Product: 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: A potential for a light system to fall in the operating room..

Recalling firm: Getinge Usa Sales Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-11-08
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K040735 — ALM X'TEN (X10) SURGICAL LIGHT SYSTEMAlm S.A.·cleared 2004-05-21

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.