The Recall Desk
SevereFDA (Devices)·Z-2502-2018·Announced 2018-07-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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 surgic
Manufacturer
Maquet SAS
Category
Medical Device — Surgical Lighting
Hazard
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

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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