Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788

Serial numbers: 108517025, 110115554, 110144247, 110188916, 109558596, 110139748, 110166201, 110188918, 109737582, 110139769, 110177678, 110192686, 110115551, 110144245, 110185616, 109889060; UDI-DI number: 00887761967526

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. Baxter has received three complaints related to this issue, with no reported patient injury.

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 assistance. 3. Please post this communication by the impacted devices until the correction is completed to maintain user awareness. 4. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com. Log in to the portal using the account number listed in the enclosed reply instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 5. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 6. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 7. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box o