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Recall Observatory FDA recall evidence

Device product

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

Z-2076-2012

May 25, 2012

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 62007
Status
Terminated
Classification
Class I
Quantity
112,912 units total (106,888 units in US)
Official record key
device-enforcement:Z-2076-2012

Official wording

Reason: 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.

Code information: not available

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.