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Recall Observatory FDA recall evidence

Device product

Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, 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 Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography

Z-1829-2012

May 21, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 62052
Status
Terminated
Classification
Class II
Quantity
433 units
Official record key
device-enforcement:Z-1829-2012

Official wording

Reason: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

Code information: Units with cable swivel delivered from 2007

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement