| TGA Action ID |
RC-2026-RN-00799-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TruSystem 7000 and TruSystem 7500
TruSystem 7500 Mobile Column Product Code:1717023 Serial Numbers:108842483, 108904671, 108987490, 108596073, 108681744 TruSystem 7500 Hybrid Plus (FC) Product Code:1854087 Serial Numbers:110086092, 110086119, 110086125
TruSystem 7000 (dV) Product Code:1841049 Serial numbers:109939403
TruSystem 7000 (MBW) Product Code:1841048 Serial Numbers:110155027, 110155028, 110155030, 110155032, 110155033 |
| ARTG Number |
407075, 407076 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Baxter Healthcare (Hill Rom Pty Ltd) is aware of certain TruSystem 7000 and TruSystem 7500 Surgical Tables having a problem with the main lift mechanism.
Customers have reported instances in which the main lift on a TruSystem 7500 unexpectedly dropped from its set position to its lowest position during use. In these cases, the tabletop could not be raised again after the drop occurred. The problem has been associated with unexpected wear of the main lift assembly, also known as the telescopic spindle.
Affected TruSystem 7000 Surgical tables and TruSystem 7500 Surgical Tables that were distributed between May 2026 and June 2026 and TruSystem 7500 Surgical Tables that were distributed between April 2021 and February 2026.
Serious or critical adverse health consequences may occur, including traumatic injury, airway compromise, and surgical procedure complications, among others. Baxter has received three complaints related to this problem, with no reported patient injury. No complaints related to this problem have been identified in Australia. |
| Instructions for Customers/Users |
Although Baxter’s risk assessment to date has not identified a clear cause for this problem, customers can continue to use the table ensuring they continue to monitor the table as instructed in the applicable IFU during use for unusual noises or changes in performance.
If an unusual noise is observed, discontinue use of the affected product and contact Baxter Technical Service for assistance.
A Baxter representative will contact facilities when the correction for this problem becomes available.
Baxter expects to begin contacting customers with more information about the correction by the end of 2026. |
| Action Commencement Date |
15/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 445 576 - Baxter Healthcare Customer Service |