Maquet XTen OR Light Systems Recalled for Potential Fall Hazard
The FDA is recalling multiple Maquet XTen OR Light System models because they may unexpectedly fall in the operating room. The recall affects 236,793 units distributed nationwide and globally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a risk-of-harm product (surgical light fixture with potential to fall in an operating room) where no injuries have been reported. The hazard is a structural defect that could cause injury, but the source text contains no reports of actual incidents.
Plain-English summary
The FDA is recalling Maquet XTen OR Light Systems manufactured by Getinge Usa Sales Inc. The affected products include multiple models such as the 3001 HMD14, XTen DUO, X10AXL DF, X10AXL SF, X10AXL+ DF, X10AXLDUO, and other variants with various catalog numbers. In total, 236,793 units have been recalled.
The recall is due to a potential for the light systems to fall in the operating room. This defect poses a risk of injury to patients and surgical staff in the affected facilities.
The affected light systems were distributed nationwide in the United States and globally. They are used in operating room environments for surgical lighting.
Healthcare facilities currently using these light systems should contact Getinge Usa Sales Inc immediately for guidance on repair, replacement, or corrective actions. Do not continue operating units that show signs of instability or mounting problems.
The recalled product
- 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, X1
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- falling-light
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems affected
Distribution
Distributed nationwide across the United States.
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