Maquet Orchide OR Light Systems recalled due to fall risk
Getinge USA is recalling Maquet Orchide OR Light Systems due to a potential for light fixtures to 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 a risk-of-harm product where no injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High). Although FDA Class II indicates potential hazard, the absence of reported incidents or hospitalizations prevents a higher score.
Plain-English summary
Getinge USA Sales Inc is recalling Maquet Orchide OR Light Systems used in operating rooms nationwide and internationally. The affected systems include multiple model numbers and catalog numbers as identified by FDA.
The recalled light systems have a potential to fall during use in the operating room. This defect could pose a risk to surgical personnel and patients, though no injuries have been reported at this time.
The systems were distributed across the United States and globally. A total of 236,793 units are affected by this recall.
Hospitals and surgical facilities using these light systems should immediately contact Getinge USA Sales Inc for instructions on remediation. Healthcare providers should secure or take the systems out of service until a remedy is available.
The recalled product
- Product
- Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD56880
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- Affected units
- 236,793
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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