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U.S. Department of Health and Human Services

Class 2 Device Recall Philips BV Pulsera

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 Class 2 Device Recall Philips BV Pulsera see related information
Date Posted October 27, 2011
Recall Status1 Open
Recall Number Z-0116-2012
Recall Event ID 60064
510(K)Number K010435 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Philips BV Pulsera Fluoroscopic Image Intensified X-ray
Catalog Number: 718095

Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Code Information Shipped from May 2010 to 26 Jul 2011.
S/N:
774
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Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall
Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
FDA Determined
Cause 2
Nonconforming Material/Component
Action Philips Healthcare Inc., sent an "URGENT - Field Safety Notice" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support.
Quantity in Commerce 134 units in the US
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, 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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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