| Class 2 Device Recall Philips Healthcare DigitalDiagnost System XRay | |
Date Initiated by Firm | February 09, 2015 |
Date Posted | May 19, 2015 |
Recall Status1 |
Terminated 3 on June 14, 2016 |
Recall Number | Z-1554-2015 |
Recall Event ID |
70916 |
510(K)Number | K141736 |
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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Product | Philips Healthcare DigitalDiagnost System X-Ray |
Code Information |
Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | Dusty Leppert, CHP 978-659-7892 |
Manufacturer Reason for Recall | The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j). |
FDA Determined Cause 2 | Software design (manufacturing process) |
Action | Philips Healthcare Planned action:
1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem.
2. Philips engineers will install the software.
3. Philips engineers will perform testing to ensure the software update was effective.
4. Corrections are to be made free of charge
5. Corrective actions should be completed by August 15, 2015
For further questions call (978) 659-7892 |
Quantity in Commerce | 54 DigitalDiagnost |
Distribution | Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and 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 = MQB
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