Z-1098-2013Class I

Alaris PC unit model 8015 with software version 9.12

Name: Z-1098-2013 Alaris PC unit model 8015 with software version 9.12
Creator: Carefusion Corporation
Published: 2013-03-06
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-03-06 / Terminated / root cause: software

FDA source

Carefusion Corporation began a recall of Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for... on 2013-03-06. FDA classified it as Class I and gives the reason as "The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1098-2013
Classification: Class I
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-04-15
Terminated: 2014-09-02
Recalling firm: CareFusion 303, Inc
Product: Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Product code: FRN Pump, Infusion
Reason for recall: The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
Root cause tag: software
FDA root cause: Software design
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229.
Quantity in commerce: 9,241 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
Product codes and lots: unit model 8015 with software version 9.12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1098-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

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)