22
Aug
2012

Philips Easy Diagnost Classic xray Cl ll

0

Company:Philips Healthcare Inc.
Date of Enforcement Report 8/22/12
Class ll:

PRODUCT

Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. Z-2208-2012

REASON
Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover MA on 7/11/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 units

DISTRIBUTION
Worldwide

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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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