Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment
Baxter is recalling the TruSystem 7500 Hybrid 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: FDA Class II medical device. No deaths, injuries, or illnesses are reported in the source. The hazard involves loss of a device function in emergency mode, which constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Baxter Healthcare Corporation is recalling the TruSystem 7500 Hybrid (SC), Product Code 1854086. The device is affected by a software issue that prevents the upper back section from being operable or adjustable when the emergency mode function is enabled.
Eight units have been distributed nationwide in the United States. The recalled devices carry UID/DI 00887761974074 and include all serial numbers manufactured until November 14, 2024. Users should contact Baxter to determine if their device serial number is affected and to receive guidance on corrective actions.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 8
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 00887761974074
- 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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