FDA recall Z-1734-2019

Maquet Cardiovascular Us Sales, Llc · Class II · device

Product

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

Reason for recall

User may suffer an electric shock when coming in contact with the exposed electronic components

Distribution

Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG KONG HONDURAS HUNGARY ICELAND INDIA IRAN IRELAND ISRAEL ITALY JAPAN JORDAN KUWAIT LATVIA LEBANON LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVA MONTENEGRO MOROCCO MYANMAR NETHERLANDS NAMIBIA NORWAY NEW ZEALAND PAKISTAN PARAGUAY PERU PHILIPPINES POLAND PORTUGAL ROMANIA SAUDI ARABIA SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TURKEY TURKMENISTAN UKRAINE UNITED ARAB EMIRATES URUGUAY UNITED KINGDOM VIETNAM

Key facts

Status
Terminated
Initiation date
2019-05-06
Report date
2019-06-12
Termination date
2022-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2019