Maquet recalls VOLISTA StandOP Surgical Lights with potential for cracked light heads that could cause surgical infections. Affected models include VLT400SF STP with 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 because the light head forks might crack during use, risking surgical infections. This could affect patients during procedures if particles fall into the surgical field.
The coating on the light head forks may crack, allowing small particles to fall into the surgical field during surgery. These particles could potentially cause infections in patients if they enter the surgical site.
Surgical teams using the VOLISTA StandOP Surgical Lights with the specified model and serial numbers are most at risk. Patients undergoing surgery with these lights could face infection if particles fall into the field.
Check for the model VLT400SF STP with serial numbers 28001, 31016, 31094, 35000, 35001, 35050, or 35051. The product was sold by Maquet Cardiovascular Us Sales, Llc.
Verify your VOLISTA StandOP Surgical Light's model number and serial number to confirm if it's affected.
The coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infections.
The affected model is VLT400SF STP with specific serial numbers: 28001, 31016, 31094, 35000, 35001, 35050, 35051.
The recall notice does not specify a remedy or replacement process.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1856-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1856-2019 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.
