Class 2 Device Recall TruSystem 7000

• Date Initiated by Firm: September 19, 2024
• Date Posted: October 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0210-2025
• Recall Event ID: 95409
• Product Classification: Table, operating-room, electrical - Product Code GDC
• Product: Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
• Code Information: a) REF 1604786, UDI/DI 00887761967533; b) REF 1604788, UDI/DI 00887761967526; c) REF 1723633, UDI/DI 00887761967519 ALL SERIAL NUMBERS
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
• FDA Determined 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://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form 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 OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. 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. 4. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. 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 on the customer portal." "For general questions regarding this communication, please contact Baxter Technical Support at 800-445-3720 (select option 2, then option 7) between 8:00 am and 6:00 pm Eastern Time, Monday th
• Quantity in Commerce: 6045 units
• Distribution: Worldwide 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.