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Class 2 Device Recall Philips Healthcare |
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Date Initiated by Firm |
September 12, 2012 |
Date Posted |
September 28, 2012 |
Recall Status1 |
Terminated 3 on July 26, 2013 |
Recall Number |
Z-2494-2012 |
Recall Event ID |
63165 |
510(K)Number |
K982795
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Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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Product |
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543.
Product Usage: Stationary radiographic System
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Code Information |
Serial number range (patient carriage) from: 00 000 00 to 09 000 543. |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact |
Beth St. Germain 978-687-1501
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Manufacturer Reason for Recall |
Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
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FDA Determined Cause 2 |
Device Design |
Action |
Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377. |
Quantity in Commerce |
536 units |
Distribution |
Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,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 and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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