FDAFDA · Food and drugs·Recall number Z-1864-2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Published July 3, 2019 · Recall initiated: May 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- 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
- Lot
- Serial Numbers: 500040 500041 500042 500043 500044 500045 500046 500049 500050 500069
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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