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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Biograph Horizon

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  Class 2 Device Recall Siemens Biograph Horizon see related information
Date Initiated by Firm February 21, 2018
Create Date May 24, 2018
Recall Status1 Terminated 3 on October 12, 2018
Recall Number Z-1930-2018
Recall Event ID 80071
510(K)Number K170904  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Code Information Code No. 10532746, 10532748
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information Contact
847-304-7700
Manufacturer Reason
for Recall		 Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Customers were notified via letter on approximately 02/21/2018. Letters were sent via certified mail or email. Instructions included to discontinue use of the system (according to the cardiac imaging protocols listed in the letter), ensure the customer advisory notice is placed in the Biograph Horizon Operator's Manual, ensure the recall information is disseminated to all operators of the system, coordinate the installation of the updated Universal Physiological Measurement Module with Siemens Healthineers, and if the equipment has been sold to forward the letter to the new owner.
Quantity in Commerce 14 units
Distribution Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
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.
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