19
May
2011

IntelliVue Clinical Information Portfolio sw Cl ll

0

Company:Philips Healthcare Inc.
Date of Enforcement Report 5/18/2011
Class ll:

PRODUCT
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011

REASON
Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter on March 16, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
387 units

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.

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