FDAFDA · Food and drugs·Recall number Z-1652-2014
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
Published June 4, 2014 · Recall initiated: April 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
- Lot
- material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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