Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings 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 is classified as FDA Class II and involves a risk of patient infection during surgery, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 9 units of the Maquet VOLISTA StandOP Surgical Lights (Model: VST66SF, Product Code: ARDVST229036A). The recall is due to a potential defect where the coating on the light head forks may crack.
The agency classifies this as a Class II recall. The hazard is that particles from the cracked coating could fall into the surgical field during an operation, which may result in patient infection. The affected units have serial numbers 500003, 500004, 500005, 500006, 500007, 500010, 500011, 500012, and 500013.
These products were distributed worldwide, including in the United States and numerous international locations. Healthcare facilities and users should check their inventory for the affected serial numbers and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 9
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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