Home / Recalls / Maquet Cardiovascular Us Sales, Llc / Z-1862-2019

Z-1862-2019 Class II Terminated

Recalled by Maquet Cardiovascular Us Sales, Llc — Wayne, NJ

FDA device recall Z-1862-2019 was initiated by Maquet Cardiovascular Us Sales, Llc on May 28, 2019 and is designated Class II. 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 inf… The recall status is terminated (terminated July 10, 2023). Affected quantity: 2 units.

Recall Details

Product Type: Devices
Report Date: July 3, 2019
Initiation Date: May 28, 2019
Termination Date: July 10, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Product Description

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

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 Pattern

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

Code Information

Serial Numbers: 500055 500062

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