—#126662

Product

Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072485
Affected lot / code info: material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855

Why it was recalled

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.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.

Timeline

Recall initiated: 2014-04-01
Posted by FDA: 2014-05-23
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.