Date Initiated by Firm |
July 07, 2016 |
Create Date |
August 26, 2016 |
Recall Status1 |
Terminated 3 on July 14, 2020 |
Recall Number |
Z-2670-2016 |
Recall Event ID |
74616 |
510(K)Number |
K141979
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ FD20/15 OR Table 722059
|
Code Information |
UNIQ with release R1.0 |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
978-659-3000
|
Manufacturer Reason for Recall |
Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
|
FDA Determined Cause 2 |
Component change control |
Action |
Philips sent an Urgent - Field Safety Notice dated June 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Philips Field Service Engineers will replace the affected DCPS free of charge.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
For further questions regarding this recall please call (978) 659-3000. |
Quantity in Commerce |
1536 devices (includes both Allura and UNIQ) |
Distribution |
Nationwide, Canada, Algeria
Argentina
Australia
Austria
Bahrain
Bangladesh
Belgium
Brazil
Brunei Darussalam
Bulgaria
CHILE
China
Colombia
Croatia
Cuba
Cyprus
Czech Republic
Denmark
Dominican Republic
Ecuador
Egypt
Finland
France
French Polynesia
Georgia
Germany
Greece
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kenya
Korea, Republic of
Lebanon
Lithuania
Macedonia
Malaysia
Malta
Mexico
Morocco
Myanmar
Nepal
Netherlands
New Caledonia
Norway
Oman
Pakistan
Palestine, State of
PERU
Philippines
Poland
Portugal
Qatar
R¿union
Romania
RUSSIAN FEDERAT
Russian Federation
Saudi Arabia
Singapore
Slovakia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Taiwan
Tanzania
Thailand
Tunisia
Turkey
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Viet Nam |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
|