| Class 2 Device Recall Siemens Biograph Horizon |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KPS
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