The Recall Desk
HighFDA (Devices)·Z-1418-2025·Announced 2025-04-02

Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment

Baxter is recalling the TruSystem 7500 Hybrid 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: FDA Class II medical device. No deaths, injuries, or illnesses are reported in the source. The hazard involves loss of a device function in emergency mode, which constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

Baxter Healthcare Corporation is recalling the TruSystem 7500 Hybrid (SC), Product Code 1854086. The device is affected by a software issue that prevents the upper back section from being operable or adjustable when the emergency mode function is enabled.

Eight units have been distributed nationwide in the United States. The recalled devices carry UID/DI 00887761974074 and include all serial numbers manufactured until November 14, 2024. Users should contact Baxter to determine if their device serial number is affected and to receive guidance on corrective actions.

The recalled product

Product
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device
Hazard
  • software-malfunction
  • loss-of-functionality

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 00887761974074
  • All serial numbers manufactured until 11/14/2024.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category