Reported Feb 22, 2023 · Ongoing
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R…
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 mCT
a) Flow 64-4R Seismicb) S(40)-3R Seismicc) S(64)-3R Seismicd) S(40)-4R Seismice) S(64)-4R Seismicf) S(20)-3R Mobile
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047 2 S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054 3 S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091 4 S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047 5 S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076 6 S(20)-3R Mobile, UDI/DI 405686900129660028, , Material Number 10534159, Serial Number 60028 - Amount recalled
- 6 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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