Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
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: The recall involves a risk-of-harm product (potential patient infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling two units of the Maquet VOLISTA StandOP Surgical Lights, Model VLT600SF AIM STP. The affected units have serial numbers 21001 and 21002. These devices were distributed worldwide, including in the United States and numerous other countries.
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.
Healthcare facilities should stop using the affected surgical lights and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 2
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 (2)
- Serial Numbers: 21001
- 21002
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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