Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling five 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 from foreign particles in the surgical field, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling five units of the Maquet VOLISTA StandOP Surgical Lights, Model VST60SF, Product Code ARDVST229034A. The affected units have serial numbers 500007, 500008, 500010, 500011, and 500012.
The recall is due to a potential defect where the coating on the light head forks may crack. This could result in particles falling into the surgical field during surgery, which may lead to patient infection. The FDA has classified this as a Class II recall.
The affected units were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities and users should stop using the affected units and contact Maquet Cardiovascular US Sales, LLC for instructions on the recall.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 5
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)
- Serial Numbers: 500007 500008 500010 500011 500012
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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