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RecallWatchMedical Device Safety
Class IIOngoingZ-1414-2025

Baxter Healthcare Corporation recalls Baxter Stationary column TruSystem 7500 U

Baxter Healthcare CorporationDeerfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Baxter Stationary column TruSystem 7500 U, Product Code1730731
    Affected lot
    11/14/2024

What the firm is doing

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."

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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