Surgical Light Paint Particles May Fall Into Operating Field
Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.
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: This is an FDA Class II recall of surgical equipment where paint particles may contaminate the surgical field or patient body. While no illnesses or injuries have been reported, the potential consequences—infection, organ irritation, hypersensitivity reactions, or tissue granuloma—represent significant risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
The FDA has issued a Class II recall of VOLISTA StandOP Surgical Lights manufactured by Getinge Usa Sales Inc. According to the FDA, paint particles may detach from these surgical lights and fall into the operating field during procedures. In the worst case scenario, if paint particles enter the patient's body or operating field, they could cause infection, organ irritation, hypersensitivity reactions, or tissue granuloma.
The recall affects 337 units distributed in the United States and 8,594 units distributed internationally. Affected models include variants of the VLT and VST series surgical lights, which are identified by specific product codes and serial numbers.
The recalled product
- Product
- VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A…
- Manufacturer
- Getinge Usa Sales Inc
Distribution
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