FDAClass IIApril 2, 2025

Baxter TruSystem 7500 Hybrid MR IMRIS recall: Software Issue

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Why was Baxter TruSystem 7500 Hybrid MR IMRIS recalled?

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UID/DI 00887761973763, All serial numbers manufactured until 11/14/2024.

Product
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Recalling firm
Baxter Healthcare Corporation
Quantity
24 units
Distribution
US Nationwide distribution.
Recall date
April 2, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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