Siemens Medical Solutions USA, Inc.: 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.

Recall number

Z-0707-2019

Recalling firm

Siemens Medical Solutions USA, Inc.

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.

Status

Terminated

Initiated

2018-11-30

Posted

not on file

Terminated

2020-09-02

Reason

Improper design or specifications.

Root cause

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

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

Lot, serial or model codes

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

510(k) numbers

["K152880","K170904"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1000514697

Firm city

Hoffman Estates

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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