Reported Jun 29, 2016 · Terminated
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray…
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. · 810 Innovation Dr · Knoxville, TN · 37932-2562
Is this the product you have?
- BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Lot codes and dates
- Serial Numbers
1001100210031004100510061007100810091010101110121013101410151016101710181019102110221023102410251026102710281029103110331034103510371038104010421043104410451046104710481049105010511053
- Serial Numbers
- Amount recalled
- 46 units
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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.
Free recall alerts
Get alerted about new Siemens Medical Solutions USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.