Cl ll Philips IntelliVue

Company: Philips Healthcare Inc.
Date of Enforcement Report 2/2/2011
Class ll:

PRODUCT
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011.

REASON
Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 15, 2010.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
200

DISTRIBUTION
Nationwide and Internationally

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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.