Recall Z-0707-2019 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
| Date | Nov 30, 2018 |
| Status | Terminated |
| Reason | Improper design or specifications. |
| Root cause | Device Design |
| Action | Siemens sent a letter to all their customers. The letter identified the affected product, problem and actions to be taken. Siemens Healthineers' service organization will contact you inQ1 of 2019 to schedule the replacement of the 70 amp CT circuit breaker, found within the PDCC cabinet of your Biograph Horizon system, with a 60 amp CT circuit breaker. Please ensure that this customer advisory notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of Biograph Horizon. If this equipment is no longer in your possession, w |
| Quantity | 171 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Ital |
| FDA record | Open on fda.gov |