FDA-Device2015-03-25Class II
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.
Siemens Medical Solutions USA, Inc.
Hazard
Radial motor drives replaced during a customer service action were incorrectly assembled backwards.
Sold states
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.
Affected count
4,856 systems (worldwide)
Manufactured in
2501 Barrington Rd, Hoffman Estates, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief