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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph Horizon

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  Class 2 Device Recall Biograph Horizon see related information
Date Initiated by Firm November 30, 2018
Create Date January 10, 2019
Recall Status1 Open3, Classified
Recall Number Z-0707-2019
Recall Event ID 81821
510(K)Number K152880  K170904  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Siemens Biograph Horizon PET/CT System,

Product Usage:
The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Code Information Material Number: 10532746 - Serial #'s: 94401, 94405, 94406, 94408, 94409, 94413, 94414, 94415, 94420, 94421, 94422, 94423, 94424, 94425, 94426, 94427, 94429, 94430, 94431, 94432, 94433, 94434, 94435, 94436, 94438, 94440, 94441, 94442, 94443, 94444, 94445, 94447, 94448, 94451, 94452, 94457, 94459, 94460, 94461, 94462, 94463, 94464, 94466, 94467, 94473, 94476, 94477, 94480, 94481, 94482, 94483, 94484, 94485, 94487, 94491, 94492, 94493, 94495, 94496, 94497, 94498, 94499, 94500, 94502, 94504, 94505, 94506, 94508, 94510, 94512, 94513, 94516, 94517, 94518, 94519, 94520, 94521, 94522, 94525, 94530, 94531, 94532, 94533, 94534, 94537, 94538, 94540, 94541, 94542, 94543, 94547, 94549, 94550, 94551, 94555, 94556, 94558, 94559, 94560, 94562, 94563, 94565, 94566, 94567, 94569, 94574, 94576, 94580, and 94590 Material Number: 10532748 - Serial #'s: 94402, 94407, 94410, 94412, 94416, 94417, 94418, 94419, 94428, 94446, 94449, 94450, 94453, 94454, 94455, 94456, 94465, 94470, 94471, 94472, 94475, 94478, 94479, 94486, 94488, 94489, 94490, 94494, 94501, 94503, 94507, 94524, 94527, 94528, 94536, 94539, 94544, 94546, 94548, 94552, 94554, 94557, 94561, 94575, 94585, 94587, and 94593  
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
Improper design or specifications.
FDA Determined
Cause 2
Device Design
Action Siemens sent a letter to all their customers. The letter identified the affected product, problem and actions to be taken. Siemens Healthineers' service organization will contact you inQ1 of 2019 to schedule the replacement of the 70 amp CT circuit breaker, found within the PDCC cabinet of your Biograph Horizon system, with a 60 amp CT circuit breaker. Please ensure that this customer advisory notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of Biograph Horizon. If this equipment is no longer in your possession, we kindly ask that you forward this letter to the new owner of the equipment and please inform Siemens Healthineers about the change in ownership. If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121
Quantity in Commerce 171
Distribution Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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