Software Malfunction Disables Back Control on Baxter TruSystem 7500
Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled 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: The TruSystem 7500 is a medical device subject to FDA Class II recall for a software malfunction that disables critical functionality during emergency mode operation. No injuries or illnesses have been reported; however, the functional failure of critical components on a high-risk medical device constitutes a risk-of-harm condition meeting the threshold for High severity.
Plain-English summary
Baxter Healthcare Corporation is recalling the TruSystem 7500 medical device (Product Code 4091000). Approximately 1,709 units were distributed nationwide. The device is identified by UID/DI 00887761968639, and all serial numbers manufactured on or before November 14, 2024 are affected.
A software issue in the device causes the upper back section to become inoperable and unable to be adjusted when the emergency mode function is enabled. This malfunction may impact the device's functionality during emergency operation.
Healthcare providers and facilities with affected devices should contact Baxter Healthcare Corporation for further information and guidance regarding this issue.
The recalled product
- Product
- Baxter TruSystem 7500, Product Code 4091000
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 1,709
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 00887761968639
- 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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