Software Malfunction Disables Back Control on Baxter TruSystem 7500
Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.
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: The TruSystem 7500 is a medical device subject to FDA Class II recall for a software malfunction that disables critical functionality during emergency mode operation. No injuries or illnesses have been reported; however, the functional failure of critical components on a high-risk medical device constitutes a risk-of-harm condition meeting the threshold for High severity.
Plain-English summary
Baxter Healthcare Corporation is recalling the TruSystem 7500 medical device (Product Code 4091000). Approximately 1,709 units were distributed nationwide. The device is identified by UID/DI 00887761968639, and all serial numbers manufactured on or before November 14, 2024 are affected.
A software issue in the device causes the upper back section to become inoperable and unable to be adjusted when the emergency mode function is enabled. This malfunction may impact the device's functionality during emergency operation.
Healthcare providers and facilities with affected devices should contact Baxter Healthcare Corporation for further information and guidance regarding this issue.
The recalled product
- Product
- Baxter TruSystem 7500, Product Code 4091000
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Affected units
- 1,709
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 00887761968639
- 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.
See all 14 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Same hazard · software malfunction
See all →- HighPhilips PIC iX Essentials Patient Information System Software Recall
FDA (Devices) · 2026-09-23
- HighPhilips Patient Information Center iX Software Malfunction Recall
FDA (Devices) · 2026-09-23
- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
Similar recalls
- HighBaxter Operating Table TruSystem 7000 Recalled for Battery Short-Circuit Hazard
FDA (Devices) · 2024-10-30
- HighBaxter TruSystem 7000 Operating Tables: Battery Short-Circuits, Smoke Risk
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table TruSystem 7000 recalled for electrical hazard
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table Recalled for Battery Short-Circuit and Smoke Risk
FDA (Devices) · 2024-10-30
- HighBaxter Operating Table TruSystem 7000 U14 Recalled for Battery Short-Circuit Risk
FDA (Devices) · 2024-10-30