Agency classClass IIOur severity:High FDA (Devices)·Z-0771-2024·Announced 2024-01-24

Maquet Operating Room Light Systems Recalled Due to Fall Hazard

Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems nationwide due to a potential for the light system to fall, posing a safety risk to surgical patients and staff.

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 3/5 (High).

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: This is a risk-of-harm product (operating room light system with a potential failure mode) where no injury has been reported. FDA Class II designation and the safety-critical nature of the device in a surgical setting justify a High severity score.

Plain-English summary

Getinge Usa Sales Inc is recalling 236,793 Maquet operating room light systems, including the Hanaulux 2006/2007, Blue 100, Blue 130/90, Blue Series 30/80, and Prismatic OR Light Systems. All systems across all models are affected by this recall. The reason for the recall is a potential for the light system to fall in the operating room.

This recall affects hospitals, surgical centers, and other healthcare facilities throughout the United States using these light systems. The potential for the system to fall poses a safety risk to patients undergoing surgery and to surgical and clinical staff working in the operating room.

Healthcare facility managers and personnel using these light systems should contact Getinge Usa Sales Inc immediately for instructions on remediation. Facilities should secure the affected light systems and follow the manufacturer's guidance until the issue has been addressed.

The recalled product

Product: Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Operating Room Lighting
Hazard: fall-hazard
trauma-risk
Affected units: 236,793

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)

All systems affected

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Getinge Usa Sales Inc 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 15 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

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Same hazard · fall hazard