| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00600-1 |
| Product Name/Description |
Proteus XR/a Table Dolly Usage and Product Deinstallation Instructions
GTIN: 00840682120777
All Systems
ARTG 1676117
(GE Healthcare Australia Pty Ltd - X-ray system, diagnostic, general-purpose, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
GE HealthCare has become aware of an event involving a 3rd party service organisation that occurred while de-installing a Proteus XR/a table. The table dolly was not utilised properly, resulting in a minor injury to the person using the service tool.
During deinstallation of a Proteus patient table, the transport dolly bolts securing a dolly to the table assembly stripped when a third-party field service engineer (FSE) lowered the assembly to the floor. The intended deinstall process is to first remove the tabletop from the table assembly, and the dolly used was originally an install dolly which was not anticipated to be saved and eventually used for deinstallation.
This problem is regarding a service tool utilised to install or deinstall the x-ray table portion of the equipment and has no effect on clinical use of the equipment. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers can continue to use the Proteus XR/a as intended for clinical use.
De-installation Instructions have been released for the product. If customers have retained one of the service dollies or intend to contract a 3rd party to deinstall their Proteus XR/a, they must utilise the De-installation Instructions.
Customers are to pay attention to Section 1.4.1 of the instructions regarding the length of bolts specified for use with the dolly and ensure these specified bolts are used as required.
Customers can find the de-installation instructions on the product documentation portal by searching for Proteus XR/a De-Installation Manual or instruction number 5273026-8EN. https://www.gehealthcare.com/support/manuals.
This action has been closed out on 23/08/2024 |
| Contact Information |
1800 659 465 - GE HealthCare Service |