Alaris PC unit model 8015 recallZ-2076-2012 · CareFusion 303, Inc. · initiated May 25, 2012
Class I Terminated All recalls posted in July 2012
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
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.
FDA root cause category: Component design/selection
What the company is doing
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).
Recall details
- Recall number
- Z-2076-2012
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- May 25, 2012
- Posted by the FDA
- Jul 26, 2012
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 112,912 units total (106,888 units in US)
- Product code
- FRN
- FDA submissions
- K051641
- Distribution
- US Nationwide Distribution
Product description
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
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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