Recalls / —

—#109739

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

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K023441, K050151

Affected lot / code info

Units with cable swivel delivered from 2007

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Philips Healthcare Inc.

Address

3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

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

Timeline

Recall initiated

2012-05-21

Posted by FDA

2012-06-20

Terminated

2017-01-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #109739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.