Date Initiated by Firm | July 11, 2012 |
Date Posted | August 08, 2012 |
Recall Status1 |
Terminated 3 on March 26, 2013 |
Recall Number | Z-2156-2012 |
Recall Event ID |
62551 |
510(K)Number | K050151 |
Product Classification |
System, x-ray, stationary - Product Code KPR
|
Product | Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
Product Usage:
Philips X-ray System |
Code Information |
US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278 |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
|
For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. |
FDA Determined Cause 2 | Software design |
Action | Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative. |
Quantity in Commerce | 41 units |
Distribution | Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark.
France
Germany
Italy
Latvia
Luxembourg
Netherlands
Russian Fed.
Spain
Sweden
Switzerland
Thailand
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 = KPR
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