FDAClass IIJune 4, 2014

Siemens Linear Accelerator recall

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

Why was Siemens Linear Accelerator 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855

Product
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
9
Distribution
US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Recall date
June 4, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls