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Class 2 Device Recall Biograph Mobile |
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Date Initiated by Firm |
February 20, 2017 |
Date Posted |
February 28, 2017 |
Recall Status1 |
Terminated 3 on September 17, 2017 |
Recall Number |
Z-1422-2017 |
Recall Event ID |
76228 |
510(K)Number |
K141971
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product |
Biograph 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
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For Additional Information Contact |
Matt Shah 800-888-7436
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Manufacturer Reason for Recall |
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
Siemens 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 Commerce |
18 units |
Distribution |
Worldwide 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 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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