Class 2 Device Recall Siemens Medical Solutions USA

• Date Initiated by Firm: July 31, 2015
• Date Posted: August 20, 2015
• Recall Status: Terminated on December 23, 2016
• Recall Number: Z-2436-2015
• Recall Event ID: 71867
• 510(K)Number: K142006
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
• Code Information: Model numbers: 8717733, 10275007, 10275008, 10275009 and 10275010.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60192-2061
• For Additional Information Contact: Matt Shah; 847-304-7700
• Manufacturer Reason for Recall: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
• FDA Determined Cause: Component change control
• Action: Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If the product was sold to another party, forward the letter to the party. A local service engineer will contact the customer to schedule the servicing of the affected units by September 2015 which will consist of replacing the affected fuse with the correct amperage rating fuse. If you have any questions regarding the important notice, please contact your local service representative by calling 1-800-888-7436. Europe, Middle East and Africa: +49 9131 940 4000. Asia and Australia: +86 (21) 3811 2121.
• Quantity in Commerce: 1700
• Distribution: Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.