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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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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