Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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: December 24, 2014 Initiated: November 13, 2014 #Z-0809-2015
Product Description
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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
Possibility for system display freeze during CT interventional procedures.
Details
- Recalling Firm
- Siemens Medical Solutions USA Inc.
- Units Affected
- 8 units total
- Distribution
- Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
- Location
- Knoxville, TN
Frequently Asked Questions
What product was recalled? ▼
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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: 8 units total.
Why was this product recalled? ▼
Possibility for system display freeze during CT interventional procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0809-2015.
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