| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00546-1 |
| Product Name/Description |
Precision Surgical Table PST 500 U
Product Code: 4080100
UDI: 00887761973466
All serial numbers
ARTG 407062
(Hill-Rom Pty Ltd - PST 500 - Universal operating table, electromechanical, battery-powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
A potential problem with loose spring pins in the spindle drives has been identified. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table.
This could potentially result in unintentional patient movement or fall during surgical procedures and/or preparation for surgical procedures, including transport. This could lead to delay or interruption in therapy, ineffective CPR, and could cause critical patient harm such as major musculoskeletal or vital organ injuries. Baxter has received six complaints related to this issue; however, no serious injury was reported. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to stop using the affected units and use alternative tables, if available, until the service kits are installed.
Baxter will provide affected customers with a service kit that can be installed either by a hospital technician or by a Baxter technician/authorised representative. If the service kit is self-installed, a Baxter technician or authorised representative will follow up to verify proper installation. Further information on installing the service kits is provided in the customer letter. |
| Contact Information |
1800 445 576 - Baxter Healthcare |