PlainRecalls
FDA Devices Moderate Class II Terminated

e.cam Gamma Camera, an emission computed tomography system. It is intended 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: November 11, 2015 Initiated: June 26, 2015 #Z-0208-2016

Product Description

e.cam Gamma Camera, an emission computed tomography system. It is intended 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

Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.

Details

Units Affected
32296 e.cam Gamma Camera systems
Distribution
Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, Cameroon, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominica, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Croatia, Canary Islands, Ireland, Israel, India, Iraq, Iran, Islamic-Republic of, Italy, Jordan, Japan, Korea-Republic of, Kuwait, Lebanon, Sri Lanka, Luxembourg, Latvia, Morocco, Myanmar, Mauritius, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Russian Federation, Saudi Arabia, Sweden, Slovakia, El Salvador, Syrian Arab Republic (Syria), Thailand, Tunisia, Turkey, Taiwan, Republic of China, Ukraine, Uganda, Uzbekistan, and South Africa.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product was recalled? ▼
e.cam Gamma Camera, an emission computed tomography system. It is intended 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: 32296 e.cam Gamma Camera systems.
Why was this product recalled? ▼
Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0208-2016.

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