FDA Device recall Z-0143-2015
Merge Healthcare, Merge Hemo Programmable diagnostic computer
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Merge Healthcare, Merge Hemo Programmable diagnostic computer by Merge Healthcare, citing 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 usi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0143-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV.
Reason
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.
Identifiers
| code_info | Merge Hemo 9.x with Nellcor SpO2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2015%22
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