Alaris PC unit — Class II medical device recall Z-1606-2016
Terminated recall by CareFusion 303, Inc., reported 2016-05-11, distributed nationwide. The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacito
| Recall number | Z-1606-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2016-03-24 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2018-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB |
| Quantity | 23,397 units |
| Serial numbers | 13734283, 13734308, 13734309, 13734310, 13734312, 13734313, 13734337, 13734339, 13734345, 13734351, 13734352, 13734353, 13734354, 13734355, 13734361, 13734364, 13734365, 13734366, 13734367, 13734368, 13734370, 13734374, 13734376, 13734377, 13734379 and 475 more |
| Model numbers | 8015 |
Product
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Reason for recall
The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
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-1606-2016. 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.