Recall Z-2758-2016 ยท IYX Camera, Scintillation (Gamma)
Siemens Medical Solutions USA, Inc.
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.
| Date | Aug 5, 2016 |
| Status | Terminated |
| Reason | "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." |
| Root cause | Device Design |
| Action | 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 red |
| Quantity | 5451 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc., Aug 21, 2014 |