The Recall Desk
HighFDA (Devices)·Z-1416-2025·Announced 2025-04-02

Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode

Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.

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 with a software defect affecting emergency mode functionality. While no illnesses or injuries have been reported, the loss of critical emergency adjustment capability presents a risk of harm to patients requiring positioning adjustments.

Plain-English summary

Baxter Healthcare Corporation is recalling 2 units of the TruSystem 7500 Hybrid (MC) positioning device, Product Code 1773204. The recall affects units manufactured through November 14, 2024, and was distributed nationwide in the United States. The affected serial numbers can be identified by the UID/DI 00887761974326.

A software issue has been identified that renders the upper back section inoperable and unadjustable when the device's emergency mode function is enabled. Emergency mode is a critical safety function that medical facilities rely on for patient positioning adjustments during urgent situations.

Facilities that have received this device and may be using it are directly affected by this recall. Any healthcare provider currently operating or maintaining a TruSystem 7500 Hybrid (MC) should verify their equipment's serial number against the recall information.

Customers who believe they have affected units should contact Baxter Healthcare Corporation immediately. Do not use the device in emergency mode until the software issue has been resolved or corrected units have been deployed. Healthcare facilities should follow Baxter's guidance regarding device repair, replacement, or discontinuation of use.

The recalled product

Product
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device
Hazard
  • software-malfunction
  • operational-failure
  • emergency-mode-dysfunction

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 00887761974326
  • All serial numbers manufactured until 11/14/2024.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category