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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph Horizon PET/CT

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 Class 2 Device Recall Biograph Horizon PET/CTsee related information
Date Initiated by FirmJanuary 26, 2018
Create DateMay 02, 2018
Recall Status1 Terminated 3 on October 12, 2018
Recall NumberZ-1597-2018
Recall Event ID 79988
510(K)NumberK170904 
Product Classification positron emmission and x-ray computed tomography - Product Code JAK
ProductBiograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Code Information Software version VJ20A. 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		Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
FDA Determined
Cause 2		Software Design Change
ActionCustomers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.
Quantity in Commerce42 units
DistributionWorldwide distribution. US nationwide, Australia, France, India, Japan, and 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 = JAK
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