Class I Alaris PC unit model 8015 with SE v. 9.12

Company:Carefusion Corp..
Date of Enforcement Report 4/24/2013
Class I:

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. Recall Number Z-1098-2013

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/MANUFACTURER
Carefusion Corporation, San diego, CA on 3/6/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9,241 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.