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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.

FDA Recall Z-0914-2015 · Posted 2015-01-06

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-04-08
Date Terminated2016-12-23
Product Quantity4,462 systems

Reason for Recall

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

Firm Action

The firm, Siemens, sent a "Customer Safety Advisory Notice" letter dated April 8, 2014 to all direct accounts (customers). The letter described the product, problem and actions to be taken. The letter instructed the customers to follow the instructions in the e.cam operator's manual and the e.cam Patient Bed Safety Addendum of the operator's manual; and to always monitor the patient at all times while they are on the system during initiation of any system movement. The letter further requested that customers forward the letter to the new owner of the equipment in the event that the system is sold or transferred. Customers with questions about this letter can contact Siemens Medical Solutions USA at 800-888-7463 (Monday - Friday, 7:00 AM - 8:00 PM EST).

Root Cause

Use error

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992731E.CAM COMPUTERSiemens Medical Solutions USA, Inc. · 1999-11-10K982387E.CAM EXTRA HIGH ENERGY COLLIMATORSiemens Medical Solutions USA, Inc. · 1998-10-06K952109IP500 NUCLEAR GAMMA CAMERA SYSTEMSiemens Medical Solutions USA, Inc. · 1995-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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