MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking st
FDA device recall Z-1598-2016 · posted 2016-05-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
- Action taken
- Siemens mailed to customers on April 13, 2016, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 8 systems
- Distribution
- US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.
- Date initiated
- 2016-04-13
- Date posted
- 2016-05-03
- Date terminated
- 2017-04-17
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM AERA; MAGNETOM SKYRA (K101347) | Siemens Medical Solutions USA, Inc. | 2010-10-01 |