Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
This recall has been terminated (originally issued August 8, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- July 11, 2012
- Posted
- August 8, 2012
- Terminated
- March 26, 2013
- Recall Number
- Z-2156-2012
- Quantity
- 41 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
Distribution
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
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
Root Cause
Software design
Action Taken
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.