Recall Z-1835-2013— CareFusion 303, Inc.

Name: FDA recall Z-1835-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-17

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2013-06-17, terminated 2014-05-20. It names one FDA 510(k) clearance: K051641. Product: Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.. Reason: CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-06-17
Terminated: 2014-05-20
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 version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

Reason for recall

CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

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