Merge HEMO software.
FDA device recall Z-2341-2016 · posted 2016-08-04 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
- Action taken
- The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 37
- Distribution
- The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
- Date initiated
- 2012-07-02
- Date posted
- 2016-08-04
- Date terminated
- 2017-06-26
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |