The Recall Desk
HighFDA (Devices)·Z-1858-2019·Announced 2019-07-03

Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks 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-harm product (surgical lights) where injury (patient infection) has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling six units of the Maquet VOLISTA StandOP Surgical Lights (Model: VST60DF AIM, Product Code: ARDVST229001A). The affected units have serial numbers 500002, 500003, 500004, 500005, 500007, and 500008. The recall is due to a potential defect where the coating of the light head forks may crack.

The hazard associated with this defect is that particles from the cracked coating may fall into the surgical field during surgery. This poses a risk of patient infection. The source text does not report any specific illnesses or injuries resulting from this defect.

The affected products were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities and users of these surgical lights should stop using the affected units and contact Maquet Cardiovascular US Sales, LLC for further instructions on the recall.

The recalled product

Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Surgical Lighting
Hazard
Affected units
6

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: 500002 500003 500004 500005 500007 500008

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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