Alaris PC unit model 8000 and 8015 with Alaris PCA module… recallZ-0534-2014 · CareFusion 303, Inc. · initiated Dec 5, 2013
Class I Terminated All recalls posted in December 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 303, Inc. 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
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0534-2014
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Dec 5, 2013
- Posted by the FDA
- Dec 20, 2013
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 4824 total units (4242 units in US)
- Product code
- FRN
- FDA submissions
- K041241, K051641
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
Product description
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.
Code information (models, lots, serial numbers)
not available
Other devices under the same FDA submission
1 device cleared under K041241, 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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