Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to
FDA device recall Z-0543-2009 · posted 2009-01-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Reason for recall
- If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
- Action taken
- Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 306 of all products.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-07-23
- Date posted
- 2009-01-02
- Date terminated
- 2010-10-18
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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| MODIFICATION TO ENCOMPASS (K040896) | Heartlab, Inc. | 2004-07-16 |