Alaris PC unit model 8015 Product Usage: The device is labeled for… — Class I medical device recall Z-2076-2012
Terminated recall by CareFusion 303, Inc., reported 2012-08-01, distributed nationwide. The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply boa
| Recall number | Z-2076-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2012-05-25 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2014-05-13 |
| Distributed | Nationwide (US) |
| Model numbers | 8015 |
Product
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Reason for recall
The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.
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-2076-2012. 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.