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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph Mobile

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 Class 2 Device Recall Biograph Mobilesee related information
Date Initiated by FirmFebruary 20, 2017
Date PostedFebruary 28, 2017
Recall Status1 Terminated 3 on September 17, 2017
Recall NumberZ-1422-2017
Recall Event ID 76228
510(K)NumberK141971 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBiograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Code Information 1010, 1024, 1038, 44976, 45509, 45530, 45573, 45583, 45601, 45604, 45619, 45621, 45627, 45639, 45640, 45646, 45655, 45658 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information ContactMatt Shah
800-888-7436
Manufacturer Reason
for Recall		The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
FDA Determined
Cause 2		Labeling Change Control
ActionSiemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.
Quantity in Commerce18 units
DistributionWorldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
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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