Baxter TruSystem 7500 Hybrid Plus software issue affects emergency mode operation
Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted 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 with a functional safety issue affecting a critical device function during emergencies. No injuries or illnesses have been reported. The hazard is genuine—inability to operate in emergency mode—but remains precautionary since no actual patient harm has been documented. This meets the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling 48 TruSystem 7500 Hybrid Plus (SC) units with Product Code 1854088 manufactured until November 14, 2024.
The recall is due to a software issue that causes the upper back section to become inoperable and non-adjustable when the emergency mode function is enabled. This prevents adjustments to the upper back section during emergency situations.
All units with serial numbers manufactured before November 14, 2024, are affected nationwide. Healthcare facilities using these devices should contact Baxter Healthcare Corporation for further guidance.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 48
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 00887761974050
- 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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