Alaris PC Unit Software V9.12
April 23, 2013
A Class I recall was issued by FDA to Alaris customers on March 6, 2013, describing communication errors with the Alaris Point-of-Care (PC) Unit (model 8015) with software version 9.12. Communication errors may occur when toggling between screens when the affected unit is attached to the Alaris EtCO2 module (model 8300) or the Alaris SpO2 module (model 8210 and model 8220).
When these communication errors occur, the Alaris PC Unit will sound an audible alarm and the modules will show a “Communications Error” message and a flashing red light. When the communication error occurs, the infusion will continue as programmed. However, the keys on the Alaris PC Unit will no longer function, with the exception of the “System On” key. Pressing the “System On” key will turn off the device and terminate the infusion, which could potentially lead to patient harm.
CareFusion has a software update available to correct the issue, and will contact all affected customers by May 5, 2013, to schedule the software fix. Healthcare providers may discontinue using the EtCO2 or SpOG modules until the issue is corrected, or may continue using the modules after careful consideration of the risks and benefits to their patients. Contact CareFusion at 1-888-812-3266 to report communication errors and 1-888-562-6018 for inquiries about the recall.
More information is available at the following links:
- FDA MedWatch:
- FDA Recall:
- Company Recall:
- Company Frequently-Asked Questions:
April 23, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.