| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00075-1 |
| Product Name/Description |
Ventri and Discovery NM 530c (Full body computed tomography (CT) system)
ARTG Number: 197195 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
During a patient unload following a scan the patient's fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are being advised to exercise special care before and during patient unload:
1- Strictly adhere to the following operator's instructions: "Verify that patient limbs do not protrude from the table pallet. Using the hand held controller, move the table out and then down.
2- Please ensure that the patient is observed at all times per the operators instructions.
GE Healthcare will install a correction to all systems to mitigate the risk. |
| Contact Information |
1800 659 465 - GE Customer Care Centre |