Reported Jun 4, 2014 · Terminated

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

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • Siemens Linear Accelerator (LINAC) models
  • Product Usagedeliver X-ray radiation for therapeutic treatment of cancer
Lot codes and dates
  • material numbers and serial numbers
    • 1940035
    • 2962
    • 8139789
    • 5833
    • 8139789
    • 5899
    • 9401654
    • 2113
    • 1940035
    • 2628
    • 4504200
    • 3066
    • 4504200
    • 3361
    • 1940035
    • 3873
    • 1940035
    • 2855
Amount recalled
9

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 16, 2015 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.