Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode
Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.
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 with a software defect affecting emergency mode functionality. While no illnesses or injuries have been reported, the loss of critical emergency adjustment capability presents a risk of harm to patients requiring positioning adjustments.
Plain-English summary
Baxter Healthcare Corporation is recalling 2 units of the TruSystem 7500 Hybrid (MC) positioning device, Product Code 1773204. The recall affects units manufactured through November 14, 2024, and was distributed nationwide in the United States. The affected serial numbers can be identified by the UID/DI 00887761974326.
A software issue has been identified that renders the upper back section inoperable and unadjustable when the device's emergency mode function is enabled. Emergency mode is a critical safety function that medical facilities rely on for patient positioning adjustments during urgent situations.
Facilities that have received this device and may be using it are directly affected by this recall. Any healthcare provider currently operating or maintaining a TruSystem 7500 Hybrid (MC) should verify their equipment's serial number against the recall information.
Customers who believe they have affected units should contact Baxter Healthcare Corporation immediately. Do not use the device in emergency mode until the software issue has been resolved or corrected units have been deployed. Healthcare facilities should follow Baxter's guidance regarding device repair, replacement, or discontinuation of use.
The recalled product
- Product
- Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 2
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 00887761974326
- 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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