Baxter TruSystem 7500 U Medical Device Software Malfunction Recall
Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
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: This is a Class II FDA medical device recall involving a software malfunction that prevents a critical function (upper back adjustability) from operating during emergency mode. Although no illnesses or injuries have been reported, the functional defect in a medical device affecting emergency operation qualifies as a risk-of-harm product per the FDA severity rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling the Stationary column TruSystem 7500 U (Product Code 1730731) due to a software malfunction. When the device's emergency mode function is enabled, the upper back section becomes inoperable and cannot be adjusted.
The recall affects 2 units distributed nationwide in the United States. All units manufactured until November 14, 2024 are included (UID/DI: 00887761974371).
This is a Class II FDA medical device recall. No illnesses or injuries have been reported.
The recalled product
- Product
- Baxter Stationary column TruSystem 7500 U, Product Code 1730731
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Column System
- Affected units
- 2
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 00887761974371
- 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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