Siemens Medical Solutions USA, Inc. recalls E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ

Recalled March 25, 2015 · FDA recall Z-1297-2015 · Siemens Medical Solutions USA

Hazard

Radial motor drives replaced during a customer service action were incorrectly assembled backwards. · FDA Class II

Units

4,856 systems (worldwide)

Sold at

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.

Description

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

Product

E.CAM emission computed tomography 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.

Manufacturer(s)

Siemens Medical Solutions USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →