Reported Feb 22, 2023 · Ongoing

SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

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 Vision
    • a) 450
    • b) 600
    • c) 600 Edge
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106
2600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120
3UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116
4600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068
Amount recalled
4 units

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, 6:58 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.