CLASS II Device recall · Reported 1 Jul 2020 · FDA Enforcement Report
Merge Application Server recalled by Merge Healthcare
Merge Healthcare is recalling Merge Healthcare Merge Application Server, distributed nationwide in the US. The recall was initiated on 8 May 2020 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-2403-2020
- FDA event ID
- 85633
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2020
- FDA classified
- 19 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Medical Software
Timeline
| 8 May 2020 | Recall initiated by company | |
| 19 Jun 2020 | Classified by FDA | +42 days |
| 1 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
Product as listed by the FDA
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Where it was distributed
US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.
Nationwide ArizonaCaliforniaConnecticutGeorgiaIllinoisIndianaMissouriNew MexicoOhioOklahomaOregonTennesseeTexasUtahVirginiaVermont
Questions about this recall
Is Merge Application Server recalled?
Yes. Merge Healthcare recalled Merge Application Server on 8 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2403-2020.
Why was it recalled?
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
Which lots are affected?
Merge Cardio versions 10.X and 11.X with Knowledge Base versions 3.3, 3.4, 3.5 or 5.0 installed on or before February 21, 2020. Version 10.0 Pre-UDI Application server PN 88-00528-00; Workstation PN:88-00534-00 Version 10.1.2 Pre-UDI Application server PN 88-01075-00; Workstation PN 88-01078-00 Version 10.2 P2 Pre-UDI Application Server PN 88-01203-00 Version 10.2 P1&P2 Pre-UDI Software Release PN 87-00247-00 Version 10.3 UDI: (01) 00842000100041(10)10.3.0.1137(11)170104 Application server PN: 88-01233-00; Workstation PN 88-01239-00 Version 10.3 Patch 1 UDI: (01)00842000100041(10)10.3.0.2009(11)170309 Software Release PN 88-01319-00; Workstation PN: 88-01320-00 Version 10.3.1 UDI: (01) 00842000100041 (10) 10312135 (11) 171024 Application Server PN: 88-01426-00; Workstation PN 88-01430-00 Version 11.0.2 UDI: (01)00842000100416(10)11.0.2.1523(11)180809 Application Server Installation PN: 88-01570-00; Workstation Installation PN 88-01571-00 Version 11.0.3 UDI: (01)00842000100416(10)11.0.3.1601(11)181019 Workstation Installation PN: 88-01589-00 Version 11.1.1 UDI: (01)00842000100751(10)11.1.1(11)190724 Application Server 30-01650-00; Workstation PN:30-01654-00
Where was it sold?
US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.
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 |
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