CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report
Merge Hemo, 10, 20.0, 20.1 20.2, 30 recalled by Merge Healthcare
Merge Healthcare is recalling Merge Hemo, 10, 20.0, 20.1 20.2, 30, 40.0, 40.1, 40.2 with Massimo Phasein End Tidal CO2, distributed nationwide in the US. The recall was initiated on 21 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2347-2015
- FDA event ID
- 71814
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2015
- FDA classified
- 6 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jan 2015 | Recall initiated by company | |
| 6 Aug 2015 | Classified by FDA | +197 days |
| 12 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Product as listed by the FDA
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Where it was distributed
Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisLouisianaMassachusettsMaineMichiganMissouriNorth CarolinaNorth DakotaNew Mexico
Questions about this recall
Is Merge Hemo, 10, 20.0, 20.1 20.2, 30, 40.0, 40.1, 40.2 with Massimo Phasein End Tidal CO2 recalled?
Yes. Merge Healthcare recalled Merge Hemo, 10, 20.0, 20.1 20.2, 30, 40.0, 40.1, 40.2 with Massimo Phasein End Tidal CO2 on 21 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-2347-2015.
Why was it recalled?
A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Which lots are affected?
Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
Where was it sold?
Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Merge Healthcare
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Merge OrthoPACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | Merge PACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | The Merge Hemo recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Vericis, Merge Cardio recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | WI |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |