Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction
A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA medical device with a software malfunction that prevents critical functionality in a surgical context. No illnesses, injuries, or deaths have been reported, meeting the criterion for high-risk products where injury has not yet occurred.
Plain-English summary
The Baxter TruSystem 7500 Hybrid MR IMRIS (Product Code 2067886) is a surgical imaging system manufactured by Baxter Healthcare Corporation. A software issue has been identified that prevents the upper back section from being operable or adjustable when the emergency mode function is enabled.
The recall affects 24 units that were distributed nationwide. The affected devices include all units with serial numbers manufactured through November 14, 2024, identified by UID/DI 00887761973763.
No illnesses, injuries, or deaths have been reported in connection with this issue. Baxter Healthcare Corporation is conducting the recall and users should contact the manufacturer regarding available remediation or replacement options.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UID/DI 00887761973763
- All serial numbers manufactured until 11/14/2024.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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