Alaris System PC Unit Model 8015 with software versions 9 — Class II medical device recall Z-2064-2016
Terminated recall by CareFusion 303, Inc., reported 2016-07-06, distributed nationwide. A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to resto
| Recall number | Z-2064-2016 |
|---|---|
| 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 | 2016-05-12 |
| Classified | 2016-06-28 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 69,693 units |
| Serial numbers | 12430440, 12437277, 12438165, 12445513, 12446686, 12447139, 12447493, 12595289, 12597362, 12597487, 12597959, 12598051, 12598210, 12598751, 12663678, 12664969, 12665111, 12665315, 12714936, 12714994, 12826925, 12979317, 12984027, 12990540, 12992278 and 475 more |
| Model numbers | 8015 |
Product
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reason for recall
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
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-2064-2016. 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.