Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropri
FDA device recall Z-1424-2017 · posted 2017-02-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Action taken
- Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 9 units
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
- Date initiated
- 2017-02-20
- Date posted
- 2017-02-28
- Date terminated
- 2017-09-17
- 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 |