FDA Device recall Z-1098-2013
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power sup…
- FDA Device
- Class I
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class I recall of Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power sup… by Carefusion, citing the recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1098-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-03-06 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion |
| Distribution | US |
Product
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Reason
The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
Identifiers
| code_info | unit model 8015 with software version 9.12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2013%22
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