# FDA recall Z-1308-2022

> **Getinge Usa Sales Inc** · Class II · device recall initiated 2022-05-06.

## Product

VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP  ARD568811911 VLT600SF AIM STP  ARD568811961 VLT600DF AIM STP  ARDVST229000A VST60SF AIM  ARDVST229001A VST60DF AIM  ARDVST229002A VST66SF AIM  ARDVST229003A VST66DF AIM  ARDVST229034A VST60SF  ARDVST229036A VST66SF  ARDVST229037A VST66DF

## Reason for recall

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT,  GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.

## Key facts

- **Recall number:** Z-1308-2022
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-06
- **Report date:** 2022-07-06

- **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-1308-2022

## Citation

> AI Analytics. FDA recall Z-1308-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1308-2022. Source: US FDA. Licensed CC0.

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