Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 7 units of VOLISTA StandOP Surgical Lights because the 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 involves a risk of patient infection due to foreign particles entering the surgical field, which is a high-risk hazard where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 7 units of Maquet VOLISTA StandOP Surgical Lights (Model VLT400SF STP, Product Code ARD568812910). The recall is due to a potential defect where the coating of 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 have serial numbers 28001, 31016, 31094, 35000, 35001, 35050, and 35051. The products were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities should stop using the affected surgical lights and contact Maquet Cardiovascular US Sales, LLC for further instructions on the recall.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 7
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: 28001 31016 31094 35000 35001 35050 35051
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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