||June 20, 2012
|Recall Event ID
System, X-Ray, Angiographic - Product Code IZI
||Philips Multi Diagnost Eleva II with swivel cable
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
||Units with cable swivel delivered from 2007
|Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
|MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
|DESIGN: Device Design
||Philips Healthcare Imaging issued Urgent Field Safety Notice dated May 21, 2012, to accounts informing an inspection will be performed of the unit. The Cable guiding plate will be replaced. If the cables show any damage the complete cable set wll also be replaced. No action is be taken by the customer. For further information customers should call 1-800-722-9377.
For questions regarding this recall call 978-687-1501.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide)
and the countries of:
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.