—#135880

Product

AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K013826
Affected lot / code info: Model Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083

Why it was recalled

If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.

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: 2015-04-14
Posted by FDA: 2015-05-05
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.