| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00188-1 |
| Product Name/Description |
NordBed Kid (Paediatric Bed)
Nordbed kid 80x160 4-section el.back/thigh el.lower leg, CENTRAL brakes
Item number: 1655874
Lot number: 21H02001706
Nordbed kid 80x179 4-section, el rygg/lår Central brakes
Item number: 1656195
Lot number: 21H02001863, 21H02001915
Nordbed kid 80x160 4-section el.back/thigh el.lower leg, CENTRAL brakes
Item number: 1657666
Lot number: 22H02001971
ARTG 279794
(Invacare Australia Pty Ltd - Bed, paediatric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Invacare became aware of near incidents in Sweden concerning the Invacare NordBed Kid when used with Lowering Side Rails.
Therefore, Invacare has decided to improve the instructions for use (IFU) with clearer images and explanations, and they decided to take the opportunity to improve the Service Manual as well. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
-Customers are reminded on the correct use and installation of the paediatric bed when used with the Lowering Side Rail.
-Invacare decided to improve the IFU with clearer images and explanations for the NordBed Kid’s User Manual, which already explains in detail the correct use and handling of the Lowering Side Rail (NordBed Kid User Manual, Section: “4.5.1 Operating the Lowering Side Rail”).
-Invacare decided to take the opportunity to improve the Service Manual as well. |
| Contact Information |
1800460460 - Invacare Australia Pty Ltd |