Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment
A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 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 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 medical device with a real functional defect in a critical emergency feature. However, the source text does not report any injuries or illnesses associated with this defect. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling the Baxter Mobile column TruSystem 7500 U (Product Code 1730720) due to a software issue affecting the upper back section. When the emergency mode function is enabled, the upper back section becomes inoperable and cannot be adjusted.
This medical device has been distributed nationwide in the United States. Approximately 40 units are affected by this recall. All serial numbers affected were manufactured through November 14, 2024.
Users of the affected equipment should be aware of this functional limitation, especially when the emergency mode is activated. Customers should contact Baxter Healthcare Corporation for information regarding repair, replacement, or other corrective actions.
The recalled product
- Product
- Baxter Mobile column TruSystem 7500 U, Product Code 1730720
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 40
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 00887761974388
- 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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