Date Initiated by Firm | October 19, 2011 |
Date Posted | June 13, 2012 |
Recall Status1 |
Terminated 3 on January 18, 2017 |
Recall Number | Z-1538-2012 |
Recall Event ID |
61830 |
Product Classification |
System, x-ray, mobile - Product Code IZL
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Product | Philips Healthcare Practix Convenio Mobile X-ray system
Worldwide Distribution -- Nationwide |
Code Information |
n/a |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator
switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when
component supplie |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012.
For questions regarding this recall call 978-687-1501. |
Quantity in Commerce | 11 - US |
Distribution | Nationwide Distribution |
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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