Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
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: The recall involves a risk-of-harm product (surgical lights) where the hazard (particle contamination leading to infection) has not yet been reported as an actual injury or illness, fitting the 'High' severity criteria for theoretical risks in medical devices.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 12 units of the Maquet VOLISTA StandOP Surgical Lights (Product Code: ARDVST229002A, Model: VST66SF AIM). The recall involves specific serial numbers ranging from 500005 to 500028. The affected units were distributed worldwide, including in the United States and numerous international locations.
The recall is being conducted because the coating on the light head forks of the surgical lights may crack. This defect poses a risk of particles falling into the surgical field during surgery, which may result in patient infection. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities and users of the affected surgical lights should stop using the units and contact Maquet Cardiovascular US Sales, LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 12
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Maquet Cardiovascular Us Sales, Llc 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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