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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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  Class 2 Device Recall Philips Healthcare see related information
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  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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
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
For Additional Information Contact Beth St. Germain
978-687-1501
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
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
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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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