CLASS II Device recall · Reported 4 Jun 2014 · FDA Enforcement Report

Siemens Linear Accelerator (Linac) recalled

Siemens Medical Solutions USA is recalling Siemens Linear Accelerator (Linac), distributed nationwide in the US. The recall was initiated on 1 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmaterial numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855

Quantity recalled9

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1652-2014
FDA event ID: 67956
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2014
FDA classified: 23 May 2014
Reported: 4 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

1 Apr 2014	Recall initiated by company
23 May 2014	Classified by FDA	+52 days
4 Jun 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama California Illinois Maine Pennsylvania

Questions about this recall

Is Siemens Linear Accelerator (Linac) recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Linear Accelerator (Linac) on 1 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1652-2014.

Why was it recalled?

Which lots 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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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