Reported Jul 25, 2018 · Terminated
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF…
Maquet SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet SAS · Parc De Limere · Orleans · N/A
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP |
| 2 | ARD568821961 VLT600DF AIM STP QL |
| 3 | ARD568811911 VLT600SF AIM STP |
| 4 | ARD568821911 VLT600SF AIM STP QL |
| 5 | ARD568821910 VLT600SF STP QL |
| 6 | ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations. |
- Lot codes and dates
- All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.
- Amount recalled
- 151
Where it was sold
Why it was recalled
Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.
This product could cause temporary or reversible health problems — stop using it.
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