Nov

2011

Cl ll Philips MDC PACS – release R2.3 SP1

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

PRODUCT
MDC PACS – release R2.3 SP1. A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). Recall # Z-0032-2012

REASON
Clinical measurements on true size printouts may be inaccurate.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA,by letter dated August 2011.
Manufacturer: CDP LTD, PETACH TIKVA, Israel. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20 units

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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Cl ll Philips MDC PACS – release R2.3 SP1

Amy Sellers

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