The Recall Desk
HighFDA (Devices)·Z-1853-2019·Announced 2019-07-03

Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

Maquet is recalling 11 VOLISTA StandOP Surgical Lights because 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 is classified as FDA Class II. The hazard involves a risk of patient infection from foreign particles, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 11 units of the Maquet VOLISTA StandOP Surgical Lights (Model VLT600SF STP, Product Code ARD568811910). The recall is due to a potential defect where the coating on the light head forks may crack. This defect poses a risk of particles falling into the surgical field during surgery, which may result in patient infection.

The affected units were distributed worldwide, including in the United States and numerous international locations. The specific serial numbers for the recalled units are 28004, 31006, 31065, 31066, 31067, 31068, 31071, 35010, 35012, 35044, and 35045. The agency has classified this as a Class II recall.

The recalled product

Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Surgical Lighting
Hazard
Affected units
11

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 →

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