22

Dec

2011

Cl ll Philips Multi Diagnost Eleva

0

Company:Philips Healthcare Inc.
Date of Enforcement Report 12/21/11
Class ll:

PRODUCT
Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recall # Z-0371-2012

REASON
Displayed Dose Area Product (DAP) is displayed by a factor 100 too low.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated November 14, 2011.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
27 units

DISTRIBUTION
Nationwide, Denmark, France, Netherlands, Norway, Sweden, and Switzerland

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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