Baxter TruSystem 7500 Software Issue Impairs Upper Back Adjustment in Emergency Mode
Baxter Healthcare is recalling 93 TruSystem 7500 Hybrid Plus units for a software issue that renders the upper back section inoperable 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 medical device recall affecting emergency mode functionality. Although no illnesses or injuries are reported, the software defect creates a risk of harm by preventing adjustment of the upper back section during emergency situations, satisfying the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling the TruSystem 7500 Hybrid Plus (FC), Product Code 1854087. Approximately 93 units are affected, including all devices with UID/DI 00887761974067 manufactured with serial numbers until November 14, 2024. These devices were distributed nationwide in the United States.
A software issue causes the upper back section to not be operable or adjustable when the emergency mode function is enabled. This means the upper back positioning function becomes unavailable when emergency mode is active.
Users of affected devices should contact Baxter Healthcare Corporation for further information regarding this recall.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 93
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 00887761974067
- 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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