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 405686901102894792
    • Material Number 10532746
    • Serial 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:10 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.