Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part nu...
FDA Device Recall #Z-1835-2013 — Class I — June 17, 2013
Recall Summary
| Recall Number | Z-1835-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | June 17, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 303, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 26,564 total units (26,220 units for US) |
Product Description
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
Reason for Recall
CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Australia, Canada and Europe.
Lot / Code Information
1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708 10142044 1296030 1020387 3894811 1083900 10115320 1101500 1102400 1101601 10038966 19995620 3894841 1123000 1135600 1137240 1353400 3894860 1547000 1008565 1186900 6169100 10008460 3894844 1155500 3894711 10032361 10166465 3894702 10046069 10037661 10037647 3894834 3894836 10034261 1297400 1302600 1053000 1317801 3894817 3894797 10163092 10053161 1012161 3895854 10046578 1369040 1005333 1375900 10001956 3894734 3894789 3894833 10047157 1403100 1408700 10010196 3894892 3894765 1433251 1009496 1446000 1438800 1865900 1911872 10010570 19996156 10033408 1589480 1453703 1466600 1453702 6273300 10011620 1470203 1477201 1765300 1025650 10037131 19995384 1915200 1470204 1315403 10044246 1470001 1470202 19995746 6129700 1726300 1505700 10063253 10037742 1131700 10037723 4513601 1520101 1001799 10010451 4538200 10122836 1001783 1553400 1220200 3894705 1907800 1000456 6572500 19996529 10038213 3894830 1843701 10165568 1579040 10035744 10060127 3894819 3895895 1027700 1623400 1012793 10149088 3894849 1492500 1719500 10033426 1677100 1697501 1703300 6237701 1716400 1018653 10011474 1725100 1724300 1252400 6598300 1738700 6606300 10002540 19995700 10047163 1793108 3894718 1797801 10038591 1016746 1079000 1442503 19995670 10032641 1043750 1015768 1812600 1813200 1833900 1842600 1846801 1838401 1027503 1846000 10046982 10049664 10049674 10042072 10158492 10040131 1845700 3872400 3894825 3895883 3894801 3880600 3894722 3894716 3894723 3895875 3888400 6840950 10036536 3894870 1908600 1037000 1012361 19995045 10165422 10165005 10005354 10011455 1933600 3894735 1944700 980 500 10167738 111 10161003 10001154
Other Recalls from CareFusion 303, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX wit... | Feb 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1... | Dec 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis M... | Nov 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code:... | Nov 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100;... | Oct 17, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.