| TGA Action ID |
RC-2026-RN-00369-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CASE v7.0 Cardiac Testing Systems
Product Code: SU3
GTIN: 00195278617644 |
| ARTG Number |
362792 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware of the potential for electrical sparking at the printer head of CASE v7 systems. In the unlikely situation that the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of the thermal printer paper. In rare cases, ignition of the paper could result in serious thermal injury.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
Customers are to perform a visual inspection of the printer assembly to verify proper positioning of the ESD brush as outlined in the Customer Letter.
If the brush is properly positioned and aligned, continue to use the device.
If the brush appears misaligned or displaced, stop using the device and contact GE HealthCare Service.
GE HealthCare will install a new ESD static brush and conductive shield if the static brush is installed incorrectly or damaged. |
| Action Commencement Date |
25/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |