Reported Jan 16, 2019 · Terminated
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061
Is this the product you have?
- Siemens Biograph Horizon PET/CT System
- Product UsageThe 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
- Lot codes and dates
- Material Number
108 of 108 codes
10532746 - Serial #'s: 944019440594406944089440994413944149441594420944219442294423944249442594426944279442994430944319443294433944349443594436944389444094441944429444394444944459444794448944519445294457944599446094461944629446394464944669446794473944769447794480944819448294483944849448594487944919449294493944959449694497
- and 94590 Material Number
10532748 - Serial #'s: 94402944079441094412944169441794418944199442894446944499445094453944549445594456944659447094471944729447594478944799448694488944899449094494945019450394507945249452794528945369453994544945469454894552945549455794561945759458594587and 94593
- Material Number
- Amount recalled
- 171
Where it was sold
Why it was recalled
Improper design or specifications.
This product could cause temporary or reversible health problems — stop using it.
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