CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
Baxter TruSystem 7500 Hybrid MR Imris recalled by Baxter Healthcare
Baxter Healthcare is recalling Baxter TruSystem 7500 Hybrid MR Imris, 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
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.
Questions about this recall
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 96286This product is part of a recall event; the main page for the event is Baxter TruSystem 7500 Hybrid Plus (FC) recalled by Baxter Healthcare.
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Imaging Equipment recalls
All 2,341| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips EPIQ Elite Diagnostic Ultrasound System recalled | Philips Ultrasound | Labeling Errors | Nationwide |
| Device | CLASS II | GmbH Spectralis with Flex Module recalled by Heidelberg Engineering | Heidelberg Engineering | Potency & Assay | Nationwide |
| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |