—#170001

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K152880, K170904
Affected lot / code info: 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

Why it was recalled

Improper design or specifications.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2018-11-30
Terminated: 2020-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.