# FDA recall Z-1859-2019

> **Maquet Cardiovascular Us Sales, Llc** · Class II · device recall initiated 2019-05-28.

## Product

Maquet VOLISTA StandOP Surgical Lights-  Product Code: ARDVST229002A  Model: VST66SF AIM

## Reason for recall

Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk  of particles falling into the surgical field during surgery that may result in patient infection

## Distribution

Worldwide distribution.  US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA  AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA  AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA  BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA  BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN  CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND  COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES  CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND

## Key facts

- **Recall number:** Z-1859-2019
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-07-03
- **Termination date:** 2023-07-10

- **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-1859-2019

## Citation

> AI Analytics. FDA recall Z-1859-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1859-2019. Source: US FDA. Licensed CC0.

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