Recall Z-1421-2025 ยท GDC Table, Operating-Room, Electrical
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
| Date | Mar 21, 2025 (initiated Feb 25, 2025) |
| Status | Open, Classified |
| Reason | There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| Root cause | Software design |
| Action | Baxter issued an UREGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/25/2025 by letter sent via traceable means. The notice explained the issue, hazard involved, and requested the following actions be taken: "Actions to be Taken by Customers 1. Baxter will contact you to install a software upgrade in the impacted surgical table systems. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply form instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will |
| Quantity | 24 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.