Mar

2016

Cl II Philips IntelliVue Info Center iX

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/2/2016
Class lI:

PRODUCT

Philips Healthcare IntelliVue Info Center iX, A.0 866023 Recall Number Z-0856-2016

REASON
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5671

DISTRIBUTION
Worldwide

___________________________________

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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Cl II Philips IntelliVue Info Center iX

Amy Sellers

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