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.
What this means for you
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
- Hazard
- software-defect
- functional-failure
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03