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FDA Device recall Z-2437-2015

Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) c…

On 2015-08-26 the FDA classified a Class II recall of Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) c… by Siemens Medical Solutions Usa, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2437-2015
ClassificationClass II
Statusterminated
Initiated2015-07-31
Published2015-08-26
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionAK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

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.

Reason

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.

Identifiers

code_infoModel numbers: 10764801, 10764802, 10764803 and 10764804.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2437-2015%22

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