Recall Z-0919-2017 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Scope, Computed tomography x-ray system
| Date | Nov 22, 2016 |
| Status | Terminated |
| Reason | Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation. |
| Quantity | 13 systems |
| Distribution | Distributed to: IL IL GA SC SD OK NY MI IN MD AR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151749 | somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc., Mar 18, 2016 |