Reported Feb 22, 2023 · Ongoing
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
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 3R Mobile; System, Tomography, Computed, Emission
- Lot codes and dates
UDI/DI 405686901102894792Material Number 10532746Serial Number 94792
- Amount recalled
- 1 unit
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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