Maquet Hanaulux HLX2000 Operating Room Lights Recalled Due to Fall Hazard
Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.
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 FDA recall of a structural medical device with potential for falling equipment in the operating room. No illnesses or injuries have been reported, placing this in the risk-of-harm category where injury has not yet occurred.
Plain-English summary
Getinge Usa Sales Inc has recalled its Maquet Hanaulux HLX2000 OR Light Systems due to a potential for the light systems to fall in the operating room.
The affected product includes 236,793 units across multiple model numbers and catalog numbers. The systems are distributed nationwide in the United States and globally.
Operating rooms using these light systems may be at risk of equipment failure. Healthcare facilities and surgical staff should assess their systems and contact the manufacturer for guidance on remediation or replacement.
Consumers who have these systems installed should contact Getinge Usa Sales Inc for more information regarding the recall and the recommended corrective actions.
The recalled product
- Product
- Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- fall-hazard
- structural-failure
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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