PlainRecalls
FDA Devices Moderate Class II Terminated

Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

Reported: March 25, 2015 Initiated: April 11, 2012 #Z-1296-2015

Product Description

Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

Reason for Recall

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Details

Units Affected
419 systems (worldwide)
Distribution
Worldwide Distribution-US (nationwide) including the District of Columbia and the states of AL, 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, SD, TN, TX, VA, VT, WA, WI, and WV and the countries of AE, AL, AO, AR, AT, AU, BA, BD, BE, BG, BH, BO, BR, BW, BY, CA, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FA, FI, FR, GB, GE, GR, HK, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LU, LV, MA, MK, MM, MU, MX, MY, NE, NG, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PS, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, SY, TH, TN, TR, TW, UA, UG, UY, UZ, VN, YE, and ZA.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product was recalled?
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 419 systems (worldwide).
Why was this product recalled?
Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1296-2015.