MR Systems
FDA device recall Z-1087-03 · posted 2003-08-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Action taken
- The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 1374 units
- Distribution
- The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
- Date initiated
- 2003-02-28
- Date posted
- 2003-08-07
- Date terminated
- 2004-12-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO MR 2002B (K020991) | Siemens Medical Solutions USA, Inc. | 2002-06-13 |
| MAGNETOM RHAPSODY SYSTEM (K003628) | Siemens Medical Solutions USA, Inc. | 2001-01-23 |