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
This recall has been terminated (originally issued June 20, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- May 21, 2012
- Posted
- June 20, 2012
- Terminated
- January 18, 2017
- Recall Number
- Z-1829-2012
- Quantity
- 433 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
Distribution
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
Lot / Code Info
Units with cable swivel delivered from 2007
Root Cause
Device Design
Action Taken
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.