| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00850-1 |
| Product Name/Description |
Mobile OR-Table MEERA, YUNO and YUNO II
720001F0 - MEERA US w/o Drive Unit - Serial No. 221 to 226 and 701 to 711
143301B0 - Mobile OR-Table YUNO OTN EU - Serial No. 1 to 267
143302B0 - Mobile OR-Table YUNO II EU - Serial No. 1 to 62
ARTG 163023
(Getinge Australia Pty Ltd - Table, operation, ) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/09/2020 |
| Responsible Entity |
|
| Reason/Issue |
Getinge is advising they have received reports of pulled-out plastic sockets (IEC 60320-1) for mobile OR-Tables MEERA, YUNO and YUNO II where the electric parts and/or wires were exposed. If the mains cable is still connected to the mains socket, there is a risk of an electric shock to the user or third parties when touching the exposed, electronic components.
This issue was first identified for the Mobile OR-Table MEERA and actioned under RC-2019-RN-00551-1, and has now expanded to include the additional serial numbers and table models.
Six cases have been reported to Getinge where the user received an electric shock. To date, no permanent injuries have been reported to Getinge in any of these cases. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge have developed a technical solution and will contact customers to schedule a replacement and update to the affected component of their devices.
In the interim, customers are advised to perform a visual and functional check before operation. Customers should review the information in the instructions for use (IFU) regarding connection to and disconnecting from the mains socket (power source) as a matter of urgency.
If the plastic socket of the cold-device plug is pulled out, customers should not try to put it back into the housing. If electronic parts or wires are exposed, do not touch them. If this occurs customers should disconnect/detach the cable from the main socket and call their in-house technical service and arrange for the repair of the table.
This action has been closed out on 10/02/2021 |
| Contact Information |
1800 438 464 - Getinge Customer Service |