CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report

Mevatron KD-2, accelerator, Linear, Medical recalled

Siemens Medical Solutions USA is recalling Mevatron KD-2, accelerator, Linear, Medical The, distributed nationwide in the US. The recall was initiated on 25 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Model Number 8515520 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089

Quantity recalled35 systems

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-1437-2017
FDA event ID: 76459
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2017
FDA classified: 9 Mar 2017
Reported: 15 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

25 Jan 2017	Recall initiated by company
9 Mar 2017	Classified by FDA	+43 days
15 Mar 2017	Published in enforcement report	+6 days

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

Reason for recall

Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Mevatron KD-2, accelerator, Linear, Medical The recalled?

Yes. Siemens Medical Solutions USA recalled Mevatron KD-2, accelerator, Linear, Medical The on 25 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1437-2017.

Why was it recalled?

Which lots are affected?

Device Model Number 8515520 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089

Where was it sold?

Nationwide Distribution

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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