Alaris PC unit model 8015 with software version 9.12 recallZ-1112-2013 · Carefusion Corporation · initiated Mar 6, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
FDA root cause category: Software design
What the company is doing
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 actions 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. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229.
Recall details
- Recall number
- Z-1112-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 6, 2013
- Posted by the FDA
- Apr 15, 2013
- Recalling firm
- Carefusion Corporation
- Quantity
- 4,090 total units
- Product code
- FRN
- FDA submissions
- K051641
- Distribution
- Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Product description
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
Code information (models, lots, serial numbers)
not available
Other devices under the same FDA submission
1 device cleared under K051641 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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