Date Initiated by Firm | May 21, 2012 |
Date Posted | June 20, 2012 |
Recall Status1 |
Terminated 3 on January 18, 2017 |
Recall Number | Z-1829-2012 |
Recall Event ID |
62052 |
510(K)Number | K023441 K050151 |
Product Classification |
System, x-ray, angiographic - Product Code IZI
|
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 |
Code Information |
Units with cable swivel delivered from 2007 |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
|
For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement |
FDA Determined Cause 2 | Device Design |
Action | 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 | 433 units |
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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IZI 510(K)s with Product Code = IZI
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