BIOGRAPH 64 - 3 Ring, Material Number 08727450 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.
Reported: June 29, 2016 Initiated: April 22, 2016 #Z-2013-2016
Product Description
BIOGRAPH 64 - 3 Ring, Material Number 08727450 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.
Reason for Recall
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Details
- Recalling Firm
- Siemens Medical Solutions USA Inc.
- Units Affected
- 15 units
- Distribution
- Worldwide Distribution - US Nationwide
- Location
- Knoxville, TN
Frequently Asked Questions
What product was recalled? ▼
BIOGRAPH 64 - 3 Ring, Material Number 08727450 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.. Recalled by Siemens Medical Solutions USA Inc.. Units affected: 15 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2016. Severity: Moderate. Recall number: Z-2013-2016.
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