Recall Z-0809-2015— Siemens Medical Solutions USA Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA Inc., initiated 2014-11-13, terminated 2015-07-09. It names one FDA 510(k) clearance: K123737. Product: 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: Possibility for system display freeze during CT interventional procedures..
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-13
- Terminated
- 2015-07-09
- Firm location
- Knoxville, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.