Class 2 Device Recall TruSystem 7500 Hybrid Plus (FC)

• Date Initiated by Firm: September 29, 2026
• Date Posted: November 03, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0354-2027
• Recall Event ID: 100117
• Product Classification: Table, operating-room, electrical - Product Code GDC
• Product: TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087
• Code Information: Serial numbers: 107971925; UDI-DI number: 00887761974067
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 1-847-948-4770
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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
• Quantity in Commerce: 1 unit
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.