Maquet Blueline Series OR Light Systems Recalled Due to Fall Risk
Getinge Usa Sales Inc is recalling Maquet Blueline Series 30/80 operating room light systems that may fall in the operating room. No injuries have been reported.
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 an FDA Class II medical device recall involving risk of equipment falling in an operating room. Although no injuries have been reported and the hazard is described as a potential, falling operating room lights pose a risk of serious harm to patients and personnel, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Maquet Blueline Series 30/80 OR Light Systems, manufactured by Getinge Usa Sales Inc, are being recalled due to a potential for the light systems to fall in the operating room.
Approximately 236,793 units are affected across multiple model numbers distributed throughout the United States and globally. This is a Class II medical device recall issued by the FDA.
No injuries or illnesses have been reported to date. However, a light system falling in an operating room could pose a risk to patients and healthcare workers.
Healthcare facilities using affected Blueline light systems should discontinue use immediately and contact Getinge Usa Sales Inc for further guidance regarding repair, replacement, or inspection of their equipment. Additional information is available through the FDA Medical Device Recall notice.
The recalled product
- Product
- Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C,
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- equipment-fall
- falling-object-hazard
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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