Maquet Hanaulux HLX3000 Operating Room Light Systems Recall for Fall Hazard
Getinge Usa Sales Inc is recalling approximately 236,793 Maquet Hanaulux HLX3000 operating room light systems nationwide and globally due to a potential for the light system to fall in the operating room.
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 for a risk-of-harm product (operating room light systems with potential to fall). The notice does not report any injuries or illnesses. Per the rubric, risk-of-harm products without reported incidents score 3 (High).
Plain-English summary
Getinge Usa Sales Inc has recalled the Maquet Hanaulux HLX3000 OR Light Systems (Model Numbers and Catalog Numbers H3 BC - HM567811111C) nationwide and globally. The recall affects approximately 236,793 units.
There is a potential for the light system to fall in the operating room. This poses a risk to patients, surgeons, and operating room staff.
Customers who have purchased these light systems should contact Getinge Usa Sales Inc immediately for instructions on remediation or replacement.
The recalled product
- Product
- Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- 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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