FDA-Device2012-08-01Class I

Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

CareFusion 303, Inc.
Hazard

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.

Sold states
US Nationwide Distribution
Affected count
112,912 units total (106,888 units in US)
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2012

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