| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01189-1 |
| Product Name/Description |
Infant Warmer System (IWS)
Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWS
ARTG Number: 139290 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the “Heater Head” of certain Infant Warmer System (IWS) devices. Hot screws from the “Heater Head” of the IWS could fall onto the bed if the “Heater Head” assembly has been improperly serviced. This could result in thermal injury to a patient. To date, two injuries have been reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing users with interim instructions to check the screws on the "Heater Head" are tight. This will form part of the annual Preventative Maintenance check to ensure the screws are tightened. This action has been closed-out on 23/05/2017. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |