Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 11 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 patient infection during surgery, which is a high-risk hazard, but the source text does not report any confirmed illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 11 units of the Maquet VOLISTA StandOP Surgical Lights (Product Code: ARDVST229003A, Model: VST66DF AIM). The recall is due to a potential defect where the coating on the light head forks may crack.
The identified hazard is that particles from the cracked coating could fall into the surgical field during an operation. This poses a risk of patient infection. The affected units were distributed worldwide, including in the United States and numerous other countries.
Hospitals and healthcare facilities should identify the affected units by checking the serial numbers listed in the recall notice. Affected units should be removed from service and returned to Maquet for evaluation or replacement.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 11
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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