Z-1418-2025 Class II Ongoing
FDA device recall Z-1418-2025 was initiated by Baxter Healthcare Corporation on Feb 25, 2025 and is designated Class II. Reason for recall: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. The recall status is ongoing. Affected quantity: 8 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 2, 2025
- Initiation Date
- Feb 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product description
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Reason for recall
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Distribution pattern
US Nationwide distribution.
Code information
UID/DI 00887761974074, All serial numbers manufactured until 11/14/2024.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1418-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026