# FDA recall Z-0757-2024

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

## Product

Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT629117A, PWDII75DF - ARDPWT629118A, PWDII75SF - ARDPWT629119A, PWDII50DF - ARDPWT629120A, PWDII50SF - ARDPWT629121A, PWDII50SF - ARDPWT629122A, PWDII55DF - ARDPWT629123A, PWDII55SF - ARDPWT629124A, PWDII70DF - ARDPWT629125A, PWDII70DF - ARDPWT629126A, PWDII70SF - ARDPWT629127A, PWDII70SF - ARDPWT629128A, PWDII75DF - ARDPWT629129A, PWDII75SF - ARDPWT629130A, PWDII50DF - ARDPWT629131A, PWDII50SF - ARDPWT629132A, PWDII50SF - ARDPWT629133A, PWDII55DF - ARDPWT629134A, PWDII55SF - ARDPWT629135A, PWDII70DF

## 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-0757-2024
- **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-0757-2024

## Citation

> AI Analytics. FDA recall Z-0757-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0757-2024. Source: US FDA. Licensed CC0.

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