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) 450b) 600c) 600 Edge
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106 2 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120 3 UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116 4 600 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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