FDA Enforcement Class II Terminated

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

Recall: Z-2878-2016 · Reported October 5, 2016

Enforcement

Recall Number
Z-2878-2016
Event ID
75113
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Siemens Medical Solutions USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
October 5, 2016
Initiation Date
July 26, 2016
Classification Date
September 23, 2016
Termination Date
May 10, 2018
Address
40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

Description

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

Reason

Software patch installation to address several safety issues.

Code Info

Model # 08162815, 8168754 Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791

Distribution

Nationwide distribution

Quantity

103 accelerators