—#210234

Product

Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

FDA product code: JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 00887761968653, All Serial Numbers

Why it was recalled

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-09-19
Posted by FDA: 2024-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.