Recall Z-0352-2027 ยท GDC Table, Operating-Room, Electrical
Baxter Healthcare Corporation
Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788
| Date | Nov 3, 2026 (initiated Sep 29, 2026) |
| Status | Open, Classified |
| Reason | There is an issue with the main lift mechanism. The main lift may unexpectedly drop 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 issue has been associated with unexpected wear of the main lift assembly, also known as the telescopic spindle. An uncontrolled drop of the surgical table may result in an abrupt patient displacement during surgery. Serious or critical adverse health consequences may occur, including traumatic injury, airway compromise, and surgical procedure complications, among others. B |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/29/26 was sent to customers. Actions to be Taken by Customers 1. A Baxter representative will contact your facility when the correction for this issue becomes available. Baxter expects to begin contacting customers with more information about the correction by the end of 2026. 2. Customers should 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 |
| Quantity | 16 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.