Maquet Prismalix OR Light Systems recalled due to fall hazard
Getinge has recalled 236,793 Maquet Prismalix operating room light systems because the systems could potentially fall. The recall affects units distributed nationwide in the U.S. 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 medical device recall with no reported illnesses or injuries. The hazard presents a risk of harm from falling equipment in an operating room setting, but the risk remains theoretical without documented incidents.
Plain-English summary
Getinge Usa Sales Inc is recalling 236,793 Maquet Prismalix OR Light Systems across multiple models and catalog numbers. The recall is due to a potential for the light system to fall in the operating room.
The affected systems have been distributed nationwide in the United States and globally. Healthcare facilities using these operating room lights should verify they are properly secured.
Healthcare facilities using affected Maquet Prismalix OR Light Systems should contact Getinge Usa Sales Inc for instructions regarding repair or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Maquet Prismalix 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 - ARD56
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 236,793
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.
Part of a larger recall action
This product is one of 15 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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