27
Oct
2011

PCR Eleva Radiological Image Processing Syst Cl ll

0

Company: Philips Healthcare Inc.
Date of Enforcement Report 10/26/11
Class ll:

PRODUCT
PCR Eleva Radiological Image Processing System with software R.1.2. A computed radiography image processing system. Recall # Z-3205-2011

REASON
The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated June 10, 2011.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
197 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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