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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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 Class 2 Recall
Philips Healthcare
see related information
Date Posted September 28, 2012
Recall Status1 Terminated on July 26, 2013
Recall Number Z-2494-2012
Recall Event ID 63165
Premarket Notification
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, Massachusetts 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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