Alaris PC unit model 8015 with software version 9 — Class I medical device recall Z-1098-2013
Terminated recall by Carefusion Corporation, reported 2013-04-24, distributed nationwide. The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC uni
| Recall number | Z-1098-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion Corporation, San Diego, CA, United States |
| Recall initiated | 2013-03-06 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN |
| Quantity | 9,241 units |
| Reason classes | software |
| Model numbers | 8015 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1098-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.