Maquet recalls VOLISTA StandOP Surgical Lights (model VST60DF) due to potential coating cracks that could cause particles to fall into the surgical field, risking patient infection. Affected units have specific serial numbers.
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
Maquet is recalling VOLISTA StandOP Surgical Lights (model VST6:0DF) because the light head coating might crack during surgery, potentially causing particles to fall into the surgical field and lead to patient infections. This recall affects specific units with known serial numbers.
The coating on the light head forks of these surgical lights may crack during use. If particles fall into the surgical field, they could cause infections in patients during surgery. This risk is specific to the coating design and usage conditions.
Surgical staff and hospitals using the VOLISTA StandOP Surgical Lights with serial numbers 500055 or 500062 are most at risk. Patients undergoing surgery with these lights could face infection risks if particles enter the surgical field.
Check for the model VST60DF and serial numbers 500055 or 500062 on the product. The product code ARDVST229035A is also associated with these units.
Identify the model VST60DF and serial numbers 500055 or 500062 to confirm if your unit is affected.
The coating on the light head forks may crack during use, potentially causing particles to fall into the surgical field and lead to patient infections.
Check for the model VST60DF and serial numbers 500055 or 500062 on the product. The product code ARDVST229035A is also associated with these units.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1862-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1862-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
