Baxter Operating Table Column Software Issue Limits Emergency Mode Function
Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable 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: This is a Class II medical device recall with no reported illnesses or injuries. The software defect prevents proper operation of a critical surgical device during emergency mode, representing a risk-of-harm to patients. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Baxter Healthcare Corporation is recalling 403 TS7500 MOBIUS operating table columns due to a software defect affecting emergency mode functionality.
The recalled columns are affected by a software issue that prevents the upper back section from being operable or adjustable when the emergency mode function is enabled. This limits the ability to adjust the upper back during emergency procedures, which could impact the equipment's functionality in critical surgical situations.
All units manufactured through November 14, 2024, are affected. The TS7500 MOBIUS is distributed nationwide in the United States.
Healthcare facilities should verify their equipment serial numbers and contact Baxter Healthcare Corporation for guidance regarding this software issue and any necessary corrective actions or updates.
The recalled product
- Product
- Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 403
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 00887761974425
- 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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