Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
FDA Recall Z-1652-2014 · Posted 2014-05-23
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-04-01
Date Terminated2015-03-16
Product Quantity9
Reason for Recall
Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.
Firm Action
Siemen sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Elekta representative.
Root Cause
Labeling design
Distribution Pattern
US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.