Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks 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 is classified as FDA Class II. The hazard involves a risk of patient infection from foreign particles, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 11 units of the Maquet VOLISTA StandOP Surgical Lights (Model VLT600SF STP, Product Code ARD568811910). The recall is due to a potential defect where the coating on the light head forks may crack. This defect poses a risk of particles falling into the surgical field during surgery, which may result in patient infection.
The affected units were distributed worldwide, including in the United States and numerous international locations. The specific serial numbers for the recalled units are 28004, 31006, 31065, 31066, 31067, 31068, 31071, 35010, 35012, 35044, and 35045. The agency has classified this as a Class II recall.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
- 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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