Maquet VOLISTA StandOP Surgical Light Recall for Detachment Risk
Maquet is recalling 151 VOLISTA StandOP surgical lights due to a potential light head detachment issue that could cause serious injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that use of the affected device may result in serious injury to patients and medical staff if the light head detaches and drops. This aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe (4) classification.
Plain-English summary
Maquet SAS is recalling 151 units of the VOLISTA StandOP Surgical Light. The recall affects specific serial numbers manufactured between March 10, 2014, and November 17, 2016. These devices were distributed worldwide, including in numerous US states and foreign countries.
The recall is due to a potential light head detachment issue. Improper assembly of the bracket connecting the light head to the axle fork could cause the bracket to break. This may result in the light head detaching from the arm, leaving it suspended only by internal cabling.
If the light head detaches and drops, it could impact a patient or medical staff, resulting in serious injury. This risk exists during demonstration, service, or use of the device. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA…
- Manufacturer
- Maquet SAS
- Affected units
- 151
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Serial Numbers manufactured from March 10
- 2014 until November 17
- 2016 6.
Distribution
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