Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the Hear
FDA device recall Z-0143-2015 · posted 2014-10-28 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
- Action taken
- Consignees were e mailed on 5/29/14 a Merge "Important Alert" letter. The letter described the problem and the product involved in the recall. Informed consignees that they had the opportunity to replace the Nellcor SpO2 module with a Masimo SpO2 module free of charge. The letter also provided Clinical Information and the Next Steps to follow. This included to contact Merge Technical Support if they wanted to replace their Nellcor module. For questions, they can contact Lee Harrop, Director Solutions Management, Cardiology, 386-239-2224, Lee.Harrop@Merge.com. A second letter was sent Sept. 11, 2014 via e-mail. Consignees were made aware of a firmware patch available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 52
- Distribution
- Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.
- Date initiated
- 2014-09-29
- Date posted
- 2014-10-28
- Date terminated
- 2016-08-25
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |