Recall Z-0707-2019— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-11-30, terminated 2020-09-02. It names 2 FDA 510(k) clearances: K170904, K152880. Product: Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph 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: Improper design or specifications..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-30
- Terminated
- 2020-09-02
- Firm location
- Hoffman Estates, IL, United States
510(k) clearances named in this recall
2 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
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph 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
Improper design or specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.