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.
Reported: January 16, 2019 Initiated: November 30, 2018 #Z-0707-2019
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 171
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom
- Location
- Hoffman Estates, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 171.
Why was this product recalled? ▼
Improper design or specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2019. Severity: Moderate. Recall number: Z-0707-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11