Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1415-2025Class II

Baxter Floor mounting column TS 7500 U, Product Code 1730732

Baxter Healthcare Corporation / initiated 2025-02-25 / Open, Classified / root cause: software

Baxter Healthcare Corporation began a recall of Baxter Floor mounting column TS 7500 U, Product Code 1730732 on . FDA classified it as Class II and gives the reason as "There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-1415-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Baxter Healthcare Corporation
Product
Baxter Floor mounting column TS 7500 U, Product Code 1730732
Product code
KXJ Table, Radiologic
Reason for recall
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 tag
software
FDA 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 [email protected]."
Quantity in commerce
33 units
Distribution
US Nationwide distribution.
Product codes and lots
UID/DI 00887761974364, All serial numbers manufactured until 11/14/2024.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1415-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1409-2025Class IIOngoingVoluntary: Firm initiated
Z-1410-2025Class IIOngoingVoluntary: Firm initiated
Z-1411-2025Class IIOngoingVoluntary: Firm initiated
Z-1412-2025Class IIOngoingVoluntary: Firm initiated
Z-1413-2025Class IIOngoingVoluntary: Firm initiated
Z-1414-2025Class IIOngoingVoluntary: Firm initiated
Z-1415-2025Class IIOngoingVoluntary: Firm initiated
Z-1416-2025Class IIOngoingVoluntary: Firm initiated
Z-1417-2025Class IIOngoingVoluntary: Firm initiated
Z-1418-2025Class IIOngoingVoluntary: Firm initiated
Z-1419-2025Class IIOngoingVoluntary: Firm initiated
Z-1420-2025Class IIOngoingVoluntary: Firm initiated
Z-1421-2025Class IIOngoingVoluntary: Firm initiated
Z-1422-2025Class IIOngoingVoluntary: Firm initiated