Recall Z-1606-2016— CareFusion 303, Inc.

Name: FDA recall Z-1606-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-24

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-03-24, terminated 2018-06-29. It names one FDA 510(k) clearance: K051641. Product: Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.. Reason: The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Terminated: 2018-06-29
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 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

Reason for recall

The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.

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