syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mo
FDA device recall Z-1138-2008 · posted 2008-05-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
- Action taken
- Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.
- Date initiated
- 2007-12-06
- Date posted
- 2008-05-20
- Date terminated
- 2010-12-20
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO US WORKPLACE (K060992) | Siemens Medical Solutions | 2006-04-28 |