CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report

Siemens Intevo Series system recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Siemens Intevo Series system, a radiological imaging system that is a combination of a, distributed nationwide in the US. The recall was initiated on 31 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers: 10764801, 10764802, 10764803 and 10764804.

Quantity recalled185

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-2437-2015
FDA event ID: 71867
Recalling firm: Siemens Medical Solutions USA, Hoffman Estates, IL
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2015
FDA classified: 20 Aug 2015
Reported: 26 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

31 Jul 2015	Recall initiated by company
20 Aug 2015	Classified by FDA	+20 days
26 Aug 2015	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

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

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

Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

Where it was distributed

Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Siemens Intevo Series system, a radiological imaging system that is a combination of a recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Intevo Series system, a radiological imaging system that is a combination of a on 31 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2437-2015.

Why was it recalled?

Which lots are affected?

Model numbers: 10764801, 10764802, 10764803 and 10764804.

Where was it sold?

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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