CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Baxter TruSystem 7500 Hybrid MR Imris, Product recalled

Baxter Healthcare is recalling Baxter TruSystem 7500 Hybrid MR Imris, Product, distributed nationwide in the US. The recall was initiated on 25 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUID/DI 00887761973763, All serial numbers manufactured until 11/14/2024.

Quantity recalled24 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1421-2025
FDA event ID: 96286
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 25 Feb 2025
FDA classified: 21 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

25 Feb 2025	Recall initiated by company
21 Mar 2025	Classified by FDA	+24 days
2 Apr 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Baxter TruSystem 7500 Hybrid MR Imris, Product recalled?

Yes. Baxter Healthcare recalled Baxter TruSystem 7500 Hybrid MR Imris, Product on 25 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1421-2025.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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