PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: August 1, 2012 Initiated: May 25, 2012 #Z-2076-2012

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
112,912 units total (106,888 units in US)
Distribution
US Nationwide Distribution
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.. Recalled by CareFusion 303, Inc.. Units affected: 112,912 units total (106,888 units in US).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2012. Severity: Critical. Recall number: Z-2076-2012.