Class 2 Device Recall Yuno Mobile Operating Table

• Date Initiated by Firm: September 24, 2020
• Create Date: October 20, 2020
• Recall Status: Terminated on February 28, 2023
• Recall Number: Z-0132-2021
• Recall Event ID: 86495
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• Product: 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)
• Code Information: Part 143301F0: SN 1 to SN 90 Part 143301B0: SN 1 to SN 267 (OUS)
• FEI Number: 3008355164
• Recalling Firm/ Manufacturer: Maquet Cardiovascular Us Sales, Llc; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: SAME; 973-709-7000
• Manufacturer 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 Determined 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 MEERA2019@getinge.com or by faxing the form to 1-973-807-9205
• Quantity in Commerce: 62 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.