—#110911

Product

Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050151
Affected lot / code info: US Serial Numbers: 96 104 111 120 170 222 223 272 278 WW: 41 70 83 96 104 111 120 132 154 155 156 157 167 170 171 176 179 190 194 195 200 208 216 222 223 224 237 244 245 247 248 249 251 253 259 261 262 264 265 272 278

Why it was recalled

When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

Root cause (FDA determination)

Software design

Action the firm took

Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom

Timeline

Recall initiated: 2012-07-11
Posted by FDA: 2012-08-08
Terminated: 2013-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.