FDA Medical devices recall ·
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 recall
- Recall number
- Z-1419-2025
- Date
- (initiated February 25, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 93 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Why was it recalled?
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UID/DI 00887761974067, All serial numbers manufactured until 11/14/2024.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1419-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.