# FDA recall Z-0763-2024

> **Getinge Usa Sales Inc** · Class II · device recall initiated 2023-11-08.

## Product

Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3 TR - ARDINT059001C, OPT MBAT - ARD568210010A, OPT MBAT - ARD568210010C, PWD30 DUAL - ARD267800310C, PWD30 DUAL - ARD267800330A, PWD30 DUAL - ARD267800330C, PWD30 DUAL - ARD267800340A, PWD30 DUAL - ARD267800340C, PWD30+DF - ARD268300170A, PWD30+DF - ARD568424110A, PWD30+DF - ARD568424110C, PWD30+DF - ARD568424114A, PWD30+DF - ARD568424114C, PWD30+DF - ARD568424511A, PWD30+DF - ARD568424511C, PWD30+DF - ARD568424512A, PWD30+DF - ARD568424512C, PWD30+DF - ARD568424513A, PWD30+DF - ARD568424513C, PWD30+DF - ARD568484114A, PWD30+DF - ARD568484114C, PWD30+DF - ARD569424110A, PWD30+DF - ARD569424110C, PWD30+DF - ARD569424114A, PWD30+DF - ARD569424114C, PWD30+DF - ARD569424511A, PWD30+DF - ARD569424511C, PWD30+DF - AR

## Reason for recall

A potential for a light system to fall in the operating room.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-0763-2024
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-08
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0763-2024

## Citation

> AI Analytics. FDA recall Z-0763-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0763-2024. Source: US FDA. Licensed CC0.

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