PlainRecalls
FDA Devices Moderate Class II Terminated

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 588keV.

Reported: January 14, 2015 Initiated: April 8, 2014 #Z-0914-2015

Product Description

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 588keV.

Reason for Recall

There is a potential for patient finger injury on the e.cam systems.

Details

Units Affected
4,462 systems
Distribution
Worldwide Distribution: US (nationwide) including states of: AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY and Puerto Rico; and countries of: Algeria , Angola , Argentina , Australia , Austria , Azerbaijan , Bahrain , Bangladesh , Belarus , Belgium , Bolivia , Bosnia Herzeg. , Brazil , Bulgaria , Cameroon , Canada , Chile , Colombia , Costa Rica , Croatia , Cuba , Czech Republic , Dem. Rep. Congo , Denmark , Dominican Rep. , Ecuador , Egypt , El Salvador , Finland , France , Georgia , Germany , Ghana , Greece , Guam , Honduras , Hong Kong , India , Indonesia , Iran , Iraq , Ireland , Israel , Italy , Jamaica , Japan , Jordan , Kazakhstan , Kosovo , Kuwait , Latvia , Lebanon , Luxembourg , Macedonia , Malaysia , Mauritius , Mexico , Morocco , Myanmar , Nepal , Netherlands , New Zealand , Niger , Nigeria , Norway , Oman , P.R. China , Pakistan , Palestinian Ter , Peru , Philippines , Poland , Portugal , Qatar , Rep. of Yemen , Republic Korea , Romania , Russian Fed. , Saudi Arabia , Serbia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syria , Taiwan , Thailand , Trinidad,Tobago , Tunisia , Turkey , Uganda , Ukraine , United Arab Emirates , United Kingdom , Uruguay , Uzbekistan , and Vietnam.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product was recalled?
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 588keV.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 4,462 systems.
Why was this product recalled?
There is a potential for patient finger injury on the e.cam systems.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0914-2015.