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Recall Observatory FDA recall evidence

Device product

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)

Z-0133-2021

September 24, 2020

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 86495
Status
Terminated
Classification
Class II
Quantity
6 units US
Official record key
device-enforcement:Z-0133-2021

Official wording

Reason: 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

Code information: Part 143302F0-Serial Numbers: SN 1 to SN 13 Part 143302B0-Serial Numbers: SN 1 to SN 62 (OUS)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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