Baxter surgical table software issue blocks emergency back adjustment
Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.
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 an FDA Class II recall involving a software malfunction that disables critical functionality on a surgical support device. The loss of upper back adjustability during emergency mode represents a risk of harm in a high-consequence surgical environment. No injuries or adverse events have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 112 units of its TruSystem 7500 floor-mounted surgical column (Product Code 1717021). The affected units bear the UID/DI 00887761974401 and include all serial numbers manufactured through November 14, 2024. The product is distributed nationwide in the United States.
The recall is due to a software malfunction that prevents the upper back section from being operable or adjustable when the emergency mode function is enabled. This functional defect could compromise the device's usability in time-sensitive clinical situations where emergency adjustability is required.
Healthcare facilities using affected units should contact Baxter Healthcare Corporation for instructions. Users should verify their device serial number against the manufactured-date threshold and request firmware updates or replacement guidance from the manufacturer.
The recalled product
- Product
- Baxter Floor mounting column TruSystem 7500, Product Code 1717021
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 112
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 00887761974401
- 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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