Baxter TruSystem 7500 Stationary Column Recalled for Software Emergency Mode Defect
Baxter Healthcare is recalling 462 units of the TruSystem 7500 Stationary column due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
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 FDA Class II medical device recall involves a software defect that disables a critical emergency function with no reported illnesses or injuries. The loss of adjustability during emergency mode represents a potential patient safety risk in a medical device where such functionality is essential.
Plain-English summary
Baxter Healthcare Corporation is recalling 462 units of the Baxter Stationary column TruSystem 7500 (Product Code 1717020, UID/DI 00887761974418) due to a software defect discovered in the device.
The device contains a software issue that causes the upper back section to become inoperable and non-adjustable when the emergency mode function is enabled. This means that when emergency mode is activated, clinicians cannot adjust the back section of the device, which may impact the device's ability to function during critical care situations.
The affected devices were distributed nationwide throughout the United States. The recall applies to all serial numbers manufactured until November 14, 2024.
Healthcare facilities and users of this device should contact Baxter Healthcare Corporation for instructions regarding device correction, replacement, or return.
The recalled product
- Product
- Baxter Stationary column TruSystem 7500, Product Code 1717020
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Hazard
- software-defect
- emergency-function-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 00887761974418
- All serial numbers manufactured until 11/14/2024.
Distribution
Distributed nationwide across the United States.
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