Baxter TruSystem 7500 Hybrid software issue disables upper back adjustment
Baxter TruSystem 7500 Hybrid affected by software issue that prevents the upper back section from being operable or adjustable when emergency mode is enabled. Affects 10 units distributed nationwide.
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 Class II medical device recall involves a software defect that prevents critical functionality during emergency operation, creating a risk of harm. The source contains no report of injuries or adverse events, which per FDA guidance limits the severity to High.
Plain-English summary
Baxter Healthcare Corporation is recalling the Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085, due to a software issue that affects device functionality.
The software issue causes the upper back section to become inoperable and not adjustable when the emergency mode function is enabled. This prevents necessary adjustments during emergency situations when the feature is active.
The recall affects 10 units distributed nationwide. All serial numbers manufactured until November 14, 2024, are included in the recall. Healthcare facilities and providers should verify whether they have received affected units.
For information regarding remediation options, firmware updates, device replacement, or to report any related issues, users should contact Baxter Healthcare Corporation.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 10
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 00887761974081
- 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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