Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk
Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks 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 (medical device) where injury (infection) has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 65 units of the Maquet VOLISTA StandOP Surgical Lights (Model: VLT600SF AIM STP, Product Code: ARD568811911). The recall is due to a potential defect where the coating on the light head forks may crack.
If the coating cracks, particles may fall into the surgical field during surgery, which may result in patient infection. The affected units were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities should identify the affected units by checking the serial numbers listed in the recall notice and stop using them. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 65
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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