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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 Horizonsee related information
Date Initiated by FirmFebruary 21, 2018
Create DateMay 24, 2018
Recall Status1 Terminated 3 on October 12, 2018
Recall NumberZ-1930-2018
Recall Event ID 80071
510(K)NumberK170904 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBiograph 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)
ActionCustomers 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 Commerce14 units
DistributionDomestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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