Siemens Medical Solutions USA, Inc. recalls e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the b…

Recall date

August 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2758-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution: US (Nationwide) including states of: District of Columbia and Puerto Rico and countries of: Algeria, Argentina, Austria, Australia, Bangladesh, Bahrain, Belarus, Belgium, Brazil, Cameroon, Canada, Chile, China, Colombia, Congo-The Democratic Republic of the, Costa Rica, Croa…

Why it was recalled

"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

e.cam and Symbia E gamma camera systems with patient beds 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.