PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 4, 2014 Initiated: April 1, 2014 #Z-1652-2014

Product Description

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

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.

Details

Units Affected
9
Distribution
US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 9.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1652-2014.