Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.
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 (surgical lights) where injury (patient infection) 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 (Product Code: ARDVST229035A, Model: VST60DF). The recall involves serial numbers 500055 and 500062.
The recall is being conducted because 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 products were distributed worldwide, including in the United States and numerous other countries. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- 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 (1)
- Serial Numbers: 500055 500062
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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