Magnetom Trio MRI System, Model 7387074
FDA device recall Z-1404-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Action taken
- The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 1 unit
- Distribution
- The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
- Date initiated
- 2004-07-28
- Date posted
- 2004-08-24
- Date terminated
- 2005-01-25
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM TRIO SYSTEM (K013586) | Siemens Medical Systems, Inc. | 2001-12-28 |