07

Sep

2011

Cl ll Philips Medical: 865047 IntelliVue

0

Company: Philips Healthcare Inc.
Date of Enforcement Report 9/7/11
Class ll:

PRODUCT
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage. Recall #Z-3111-2011

REASON
Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, letter dated July 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
415 devices

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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