Recall Z-1098-2013— Carefusion Corporation

Name: FDA recall Z-1098-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class I · Terminated

Class I FDA medical device recall by Carefusion Corporation, initiated 2013-03-06, terminated 2014-09-02. It names one FDA 510(k) clearance: K051641. Product: Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.. Reason: The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached..

Recalling firm: Carefusion Corporation
Classification: Class I
Status: Terminated
Initiated: 2013-03-06
Terminated: 2014-09-02
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 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

Reason for recall

The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

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