Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Bi
FDA device recall Z-2248-2018 · posted 2018-06-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.
- Action taken
- The firm notified the consignees of the issue by email on May 29, 2018. The letter identified the affected product, problem and actions to be taken. They are tracking completion of the letter delivery through the hand-delivered approach. For further questions, please call (847) 304-7700. .
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 405 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2018-05-29
- Date posted
- 2018-06-08
- Date terminated
- 2020-08-24
- Location
- Hoffman Estates, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Biograph mCT Family of PET/CT Systems (K173578) | Siemens Medical Solutions USA, Inc. | 2017-12-20 |