Recall Z-0218-2025
Baxter Healthcare Corporation · initiated September 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
Codes / lots: UDI/DI 00887761973794, All Serial Numbers
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 taken
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
Details
- Recall number
- Z-0218-2025
- Initiated
- September 19, 2024
- Posted by FDA
- October 24, 2024
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- 13 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0210-2025 Class II | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF…The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0211-2025 Class II | Baxter Operating Table TruSystem 7000, Product code REF 1841046The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0212-2025 Class II | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0213-2025 Class II | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0214-2025 Class II | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0215-2025 Class II | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0216-2025 Class II | Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |
| Z-0217-2025 Class II | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385The firm received customer reports stating that the batteries and their connectors experienced electrical… | 09/19/2024Open, Classified |