The Recall Desk
HighFDA (Devices)·Z-1857-2019·Announced 2019-07-03

Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of patient infection from foreign particles in the surgical field, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling two units of the Maquet VOLISTA StandOP Surgical Lights (Product Code: ARDVST229000A, Model: VST60SF AIM). The recall involves serial numbers 500000 and 500001. These devices were distributed worldwide, including in the United States and numerous international locations.

The recall is due to a potential defect where the coating on the light head forks may crack. This condition poses a risk of particles falling into the surgical field during surgery, which may result in patient infection. The agency has classified this as a Class II recall.

Healthcare facilities should stop using the affected units and contact the recalling firm for instructions on return or repair. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Surgical Lighting
Hazard
Affected units
2

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 (1)

  • Serial Numbers: 500000 500001

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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Same hazard · infection

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