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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Verardius

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 Class 2 Recall
Philips Verardius
see related information
Date Posted October 27, 2011
Recall Status1 Open
Recall Number Z-0118-2012
Recall Event ID 60064
Premarket Notification
510(K) Number
K010435 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Code Information Shipped from Nov 2009 to 26 Jul 2011. S/N: 15 22 23 24 26 27 32 42 43 47 48 51 61 62 63 63 66 68 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 105 108 110 114 119 127 128 129 130 131 134 135 136 139 140 141 142 148 152 153 154 155 156 162 163 167 172 176 178 181 181 188 193 195 196 197 198 202 209 210 215 216 219 226 227 238 239 240 242 244 252 254 255 256 257 261 264 269 279 285 291 297 298 299 300 302 303 306 307 308 309 310 311 312 323 324 328 330 341 342 350 371 372 375 380 387 389
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 120 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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