Z-2076-2012Class I

Alaris PC unit model 8015

Name: Z-2076-2012 Alaris PC unit model 8015
Creator: CareFusion 303, Inc.
Published: 2012-05-25
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2012-05-25 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only on 2012-05-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2076-2012
Classification: Class I
Status: Terminated
Initiated: 2012-05-25
Posted: 2012-07-26
Terminated: 2014-05-13
Recalling firm: CareFusion 303, Inc
Product: Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification to schedule a visit to replace their affected power supply board on their PC unit. Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process. For questions and support contact: CareFusion Support Center at 888-562-6018 for (Recall Related Questions), Customer Advocacy at 800-854-7128, Option 1, Option 1, Option 3 or email [email protected] for (Adverse Event Reports), Technical Support at 888-812-3229 for (Technical Questions Regarding the Alaris System).
Quantity in commerce: 112,912 units total (106,888 units in US)
Distribution: US Nationwide Distribution
Product codes and lots: not available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2076-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2076-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

Product code FRN

K051641Class IIAlaris System Pc Unit, Model 8001Cardinal Health, Alaris Products / cleared 2005-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)