Recall Z-1669-2015 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
| Date | May 23, 2015 (initiated Apr 13, 2015) |
| Status | Terminated |
| Reason | Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update. |
| Root cause | Software design |
| Action | A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue. |
| Quantity | 133 total |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111292 | LUMINOS AGILE Siemens Medical Solutions USA, Inc., Jun 3, 2011 |