—#104361

Product

Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected lot / code info: 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

Why it was recalled

Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-10-04
Posted by FDA: 2011-10-27
Terminated: 2017-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.