Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment
Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall with a functional defect and no reported injuries, hospitalizations, or illnesses. The issue is software-related functional impairment rather than a direct physical hazard mechanism, warranting a Moderate severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling the Mobile column TruSystem 7500 (Product Code 1717023) due to a software issue that affects device operation. When the emergency mode function is enabled, the upper back section becomes inoperable and cannot be adjusted.
Approximately 1,596 units were distributed nationwide. All units manufactured through November 14, 2024, with UID/DI 00887761974395 are included in this recall. Healthcare facilities currently using this device should contact Baxter Healthcare Corporation for further information and guidance regarding this defect.
The recalled product
- Product
- Baxter Mobile column TruSystem 7500, Product Code 1717023
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,596
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 00887761974395
- 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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