Baxter Floor Mounting Column TS 7500 U Software Issue Affects Emergency Function
Baxter is recalling 33 units of the Floor Mounting Column TS 7500 U due to a software defect that prevents upper back adjustment 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: The product presents a documented risk of harm—a medical device that loses critical functionality (upper back adjustment) precisely when emergency mode is activated. No injuries or illnesses have been reported. FDA Class II classification without hospitalization reports places this at High per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the Floor Mounting Column TS 7500 U (Product Code 1730732) due to a software issue affecting the equipment's critical adjustment capability.
When the emergency mode function is enabled, the software defect causes the upper back section to become inoperable and unadjustable. This means the equipment cannot perform its intended adjustment function during emergency situations, which could impact care delivery.
The recall affects 33 units with nationwide US distribution. All units manufactured until November 14, 2024 are included. Healthcare facilities that have received this product should stop using the equipment in emergency mode and contact Baxter Healthcare Corporation for instructions on correcting the software issue or obtaining a replacement unit.
The recalled product
- Product
- Baxter Floor mounting column TS 7500 U, Product Code 1730732
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- software-defect
- equipment-malfunction
- loss-of-function
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 00887761974364
- All serial numbers manufactured until 11/14/2024.
Distribution
Distributed nationwide across the United States.
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