—#137252

Product

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.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111292
Affected lot / code info: Model Number of device 10762472 with serial numbers: 61034 61052 61045 61013 61054 61056 61021 61050 61053 61032 61015 61046 61028 61040 61011 61029 61048 61060 61042 61035 61014 61025 61043 61036 61038 61022 61037 61049 61044 61062 61030 61018 61027 61061 61033 61039 61047 61031 61041 61055 61019 61057 61059 61017 61051

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-05-23
Terminated: 2017-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137252. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.