Maquet Hanaulux HLX2000 Operating Room Lights Recalled Due to Fall Hazard
Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.
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 Class II FDA recall of a structural medical device with potential for falling equipment in the operating room. No illnesses or injuries have been reported, placing this in the risk-of-harm category where injury has not yet occurred.
Plain-English summary
Getinge Usa Sales Inc has recalled its Maquet Hanaulux HLX2000 OR Light Systems due to a potential for the light systems to fall in the operating room.
The affected product includes 236,793 units across multiple model numbers and catalog numbers. The systems are distributed nationwide in the United States and globally.
Operating rooms using these light systems may be at risk of equipment failure. Healthcare facilities and surgical staff should assess their systems and contact the manufacturer for guidance on remediation or replacement.
Consumers who have these systems installed should contact Getinge Usa Sales Inc for more information regarding the recall and the recommended corrective actions.
The recalled product
- Product
- Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF…
- Manufacturer
- Getinge Usa Sales Inc
- 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 →Related recalls
Same manufacturer · Getinge Usa Sales Inc
See all →- SevereSevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk
FDA (Devices) · 2025-02-19
- HighOperating Table May Stop Unexpectedly During Surgery Due to Control Error
FDA (Devices) · 2024-11-20
- ModerateGetinge MEERA CL Mobile Operating Table Recalled for Intermittent Movement Errors
FDA (Devices) · 2024-11-20
- HighMEERA CL Mobile Operating Table Control Malfunction Recall
FDA (Devices) · 2024-11-20
- ModerateGetinge MEERA CL mobile operating table recalled for sporadic movement errors
FDA (Devices) · 2024-11-20
Same hazard · fall hazard
See all →- CriticalHarkla Recalls Children's Sensory Swings Due to Fall Hazard
CPSC · 2026-10-29
- High
- Severe
- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- High
Similar recalls
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighTrumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard
FDA (Devices) · 2016-01-06
- HighGetinge Operating Table System Recalled for Hydraulic Leakage Risk
FDA (Devices) · 2021-03-31
- SevereMaquet Flat Screen Monitor Holder Recalled for Grounding Non-Compliance
FDA (Devices) · 2019-03-13
- HighMaquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk
FDA (Devices) · 2015-06-03
- HighMaquet PowerLED 700 Surgical Light Recall Due to Detaching Module
FDA (Devices) · 2014-06-18