Date Initiated by Firm | August 08, 2014 |
Date Posted | October 09, 2014 |
Recall Status1 |
Terminated 3 on December 03, 2014 |
Recall Number | Z-0022-2015 |
Recall Event ID |
69197 |
510(K)Number | K002016 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system |
Code Information |
Model Number: Integris Allura 15-12 Serial Number: 16741023 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | Philips had discovered through a field service testing where a device failed to comply with a Federal standard. |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit.
The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance.
At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer.
For further questions please call (978) 687-1501. |
Quantity in Commerce | one system |
Distribution | US distribution to FL |
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 = OWB
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