Z-0132-2021 Class II Terminated

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

FDA device recall Z-0132-2021 was initiated by Maquet Cardiovascular Us Sales, Llc on Sep 24, 2020 and is designated Class II. 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… The recall status is terminated (terminated Feb 28, 2023). Affected quantity: 62 units US.

Recall Details

Product Type
Devices
Report Date
Oct 28, 2020
Initiation Date
Sep 24, 2020
Termination Date
Feb 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
62 units US

Product Description

Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (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 143301F0: SN 1 to SN 90 Part 143301B0: SN 1 to SN 267 (OUS)

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0132-2021
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.