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TS 7000 recallZ-0210-2025 · Baxter Healthcare Corporation · initiated Sep 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0210-2025
Status
Open, Classified
Initiated by the company
Sep 19, 2024
Posted by the FDA
Oct 24, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
6045 units
Product code
GDC
Distribution
Worldwide distribution.

Product description

Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633

Code information (models, lots, serial numbers)

a) REF 1604786, UDI/DI 00887761967533; b) REF 1604788, UDI/DI 00887761967526; c) REF 1723633, UDI/DI 00887761967519 ALL SERIAL NUMBERS

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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