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
