Z-0133-2021Class II

Yuno II Mobile Operating Table -

Name: Z-0133-2021 Yuno II Mobile Operating Table -
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2020-09-24
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2020-09-24 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for... on 2020-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0133-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-24
Posted: 2020-10-20
Terminated: 2023-02-28
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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)
Product code: FQO Table, Operating-Room, Ac-Powered
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
FDA root cause: Under Investigation by firm
Action: Getinge issued Urgent Medical Device Recall on September 24, 2020, via FedEx 2 day delivery to US consignees. The letter states reason for recall, health risk and action to take: Per the IFU, section 9.1 (Yuno) and 8.1 (Yuno II), a visual and functional check is required to be performed by a trained person before operation. Follow the instructions in section 4.2.3.1of the Yuno and Yuno II IFU regarding connecting and disconnecting from the mains socket (power source). If the plastic socket of the cold-device plug is pulled out, do not try to put it back into the housing and if there are any exposed electronic components, do not touch them. Disconnect/detach the cable from the main socket, call your in-house technical service and arrange the repair of the table. Per IFU section 9.4 (Yuno) and 8.5 (Yuno II), a defective product may not be used and may not be repaired by yourself. A Getinge Service representative will contact you to schedule the correction. This work will be done at no cost to your facility Please complete and sign the attached URGENT MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-973-807-9205
Quantity in commerce: 6 units US
Distribution: 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.
Product codes and lots: Part 143302F0-Serial Numbers: SN 1 to SN 13 Part 143302B0-Serial Numbers: SN 1 to SN 62 (OUS)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0133-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)