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.
Recall
- Recall Number
- Z-2758-2016
- Event Number
- 74395
- Firm
- Siemens Medical Solutions USA, Inc.
- FEI Number
- 1000514697
- Product Code
- IYX
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 5, 2016
- Terminated
- March 9, 2018
- Address
- 2501 Barrington Rd, Hoffman Estates, IL, 60192-2061
Description
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.
"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."
The firm, Siemens, sent a "Customer Advisory Notice" letter on 8/5/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the "safety" sections of the user manual with your staff; continue using your system under the guidelines set forth in the letter; place advisory in the system's instructions for use; and if you have sold this equipment and it is no longer in your possession, forward the notice to the new owner and inform us about the new owner of the equipment. Siemens has designed an enhancement kit to further reduce the gap in the patient bed up/down drive. Your local Siemens service organization will be contacting you to schedule this update. If you have any questions regarding this important notice, contact your local Service representative at the following numbers: America: 1-800-888-7436; Europe, Middle East, and Africa: +49 9131 940 4000 or Asia and Australia: +86 (21) 3811 2121.
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, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Great Britain, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Mauritius, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Serbia (Republic of Serbia), South Africa, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, Uzbekistan, Viet nam, and Yemen.
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