| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00439-1 |
| Product Name/Description |
Giraffe Bedded Warmers and Panda iRes Warmers
Giraffe Bedded Warmers
GTIN:00840682103923
Panda iRes Warmers
GTIN:00840682103893
All Serial Numbers starting with GBW, PBW and HDJ
ARTG: 305541
(GE Healthcare Australia Pty Ltd - Warmer, radiant, infant, mobile) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/03/2019 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware that the bedside panels and latch areas on specific Giraffe Bedded Warmers and Panda iRes Warmers can crack or break if the unit is moved using the bedside panels instead of the front handle or manoeuvring handle. If an infant impacts a bedside panel with a cracked or broken latch, the panel can disengage and fall open which would not protect the infant from falling from the warmer.
Additional actions for this recall were provided to customers on 02/08/2019 through a secondary customer letter. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE is requesting Customers:
1. Inspect the warmer bedside panels latch areas and the areas connecting the panel to the bed for any cracks or damage per the instructions and images in the Customer letter;
2. If any portion of the bedside panels or latches are cracked or broken as described, stop use of the warmer immediately;
3. Complete and return the supplied response form;
4. If the Warmer bedside panels or latches have no cracks or damage, you may continue to use the warmer and apply the Safety labels enclosed with the Customer Letter; and
5. Review the supplied Addendum and place it with your Warmer Operation and Maintenance Manual for future reference.
UPDATE Aug 2019:
Additional instructions, stickers, posters and warnings are being provided to customers along with an addendum letter. Customers are advised to make sure all procedures in the initial customer letter are complete, prior to undertaking the additional actions.
This action has been closed out on 21/02/2020 |
| Contact Information |
1800 659 465 - GE National Call Centre |