Recall Z-2076-2012— CareFusion 303, Inc.

Name: FDA recall Z-2076-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-25

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2012-05-25, terminated 2014-05-13. It names one FDA 510(k) clearance: K051641. Product: Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.. 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..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-05-25
Terminated: 2014-05-13
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products·cleared 2005-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.