FDA Device recall Z-1520-2017
Alaris System PC unit, model no. 8000 and 8015
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Alaris System PC unit, model no. 8000 and 8015 by Carefusion 303, citing reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1520-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-01 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Reason
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Identifiers
| code_info | all units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.