Drug recall
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are…
FDA recall event 76127 · Class II · Siemens Medical Solutions USA Inc.
Key facts
| Event ID | 76127 |
|---|---|
| Recall numbers | Z-0992-2017, Z-0993-2017, Z-0994-2017, Z-0995-2017, Z-0996-2017, Z-0997-2017, Z-0998-2017, Z-0999-2017, Z-1000-2017, Z-1001-2017, Z-1002-2017 |
| Recalling firm | Siemens Medical Solutions USA Inc. |
| Product type | Devices |
| Products | BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that…, Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners…, Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners…, Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that…, Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that… and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Initiation date | Dec 13, 2016 |
| Report date | Jan 18, 2017 |
| Termination date | May 8, 2017 |
| City | Knoxville |
| State | TN |
| Country | United States |
| FEI number | 1034973 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: