FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Mobile column TruSystem 7500, Product Code 1717023
- Recall number
- Z-1412-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Mobile column TruSystem 7500, Product Code 1717023
- Status
- Open, Classified
- Initiated
- 2025-02-25
- Posted
- 2025-03-21
- Terminated
- not on file
- Reason
- There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Root cause
- Software design
- Action
- Baxter issued an UREGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/25/2025 by letter sent via traceable means. The notice explained the issue, hazard involved, and requested the following actions be taken: "Actions to be Taken by Customers 1. Baxter will contact you to install a software upgrade in the impacted surgical table systems. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply form instruction sheet, even if you have no remaining inventory. 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 them according to their instructions. 4. Please forward a copy of this communication to the Medical Director/Office Manager, Director of Pharmacy, Medication Safety Officer, Purchasing Director/Head of Central Supply and any other departments within your institution who use the affected product. 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 through Friday, or email Baxter at HRC_Trumpf_Tech_Support@baxter.com."
- Quantity
- 1596 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UID/DI 00887761974395, All serial numbers manufactured until 11/14/2024.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEA
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28