Z-0534-2014Class I

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600

Name: Z-0534-2014 Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600
Creator: CareFusion 303, Inc.
Published: 2013-12-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-12-05 / Terminated / root cause: software

FDA source

CareFusion 303, Inc. began a recall of Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central... on 2013-12-05. FDA classified it as Class I and gives the reason as "CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message". 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-0534-2014
Classification: Class I
Status: Terminated
Initiated: 2013-12-05
Posted: 2013-12-20
Terminated: 2016-06-02
Recalling firm: CareFusion 303, Inc
Product: Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
Product code: FRN Pump, Infusion
Reason for recall: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
Root cause tag: software
FDA root cause: Software design
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated December 5, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to contact CareFusion Customer Advocacy at (888) 812-3266, if they experienced a SYSTEM ERROR on the Alaris PC unit. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to complete and return the enclosed Customer Response Card to expedite the corrective action process. Customers with questions were instructed to contact CareFusion Support Center at 888-562-6018, or for Technical Support call 888-812-3229.
Quantity in commerce: 4824 total units (4242 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
Product codes and lots: not available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2014	Class I	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code FRN

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)