Recall Z-0210-2025 ยท GDC Table, Operating-Room, Electrical
Baxter Healthcare Corporation
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
| Date | Oct 24, 2024 (initiated Sep 19, 2024) |
| Status | Open, Classified |
| Reason | The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| Root cause | Device Design |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/19/2024 by USPS first class. The notice explained the issue, the hazard involved, and requested the following: "Actions to be Taken by Customers 1. Once available, Baxter will contact you to implement the design improvement in the impacted surgical tables. Battery replacements must only be performed by personnel authorized, trained, and certified by Baxter. 2. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https: |
| Quantity | 6045 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.