BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomogr
FDA device recall Z-2012-2016 · posted 2016-06-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Action taken
- Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 102 units
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2016-04-22
- Date posted
- 2016-06-21
- Date terminated
- 2017-05-08
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOGRAPH TRUE PET/CT FAMILY SOFTWARE (K141971) | Siemens Medical Solutions USA, Inc. | 2014-09-12 |