Z-0133-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- February 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units US
Product Description
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
Reason for Recall
Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, MACAU, MACEDONIA, MALAYSIA, MEXICO, NEW ZEALAND, OMAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNESIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
Code Information
Part 143302F0-Serial Numbers: SN 1 to SN 13 Part 143302B0-Serial Numbers: SN 1 to SN 62 (OUS)