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U.S. Department of Health and Human Services

Class 2 Device Recall System, Xray Stationary

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 Class 2 Recall
System, Xray Stationary
see related information
Date Posted September 27, 2012
Recall Status1 Open
Recall Number Z-2465-2012
Recall Event ID 63119
Premarket Notification
510(K) Number
K982795 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Code Information Serial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Dominic Siewko
978-687-1501
Manufacturer Reason
for Recall
The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips Healthcare sent a Urgent Field Safety Notice dated August 13, 2012, to all affected customers. Notifications began the week of September 6, 2012, for US and Worldwide Customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips field service engineer will Secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (loctite). Further information or support concerning this issue, contact your local Philips representative. 1-800-722-9377.
Quantity in Commerce 93 Units
Distribution Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland 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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