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FDA · FDA event 96323 · FDA posted Mar 13, 2025
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-1304-2025 | Z-1304-2025 | Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116) | Not provided in the normalized record | Ongoing |
| Z-1305-2025 | Z-1305-2025 | Software: v1.7.2/UDI: 10885403510472 | Not provided in the normalized record | Ongoing |
Feb 18, 2025
Recall initiated
Date recorded by the FDA.
Mar 13, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 27, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.