Reported Jul 1, 2020 · Terminated
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation
- Software Release - Product UsageVERICIS 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
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published 88-00528-00Merge 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 88-01075-00Workstation PN:88-00534-00 Version 10.1.2 Pre-UDI Application server 88-01233-0000842000100041Workstation 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 88-01319-0000842000100041Workstation PN 88-01239-00 Version 10.3 Patch 1 UDI: (01)00842000100041(10)10.3.0.2009(11)170309 Software Release 88-01426-0000842000100041Workstation PN: 88-01320-00 Version 10.3.1 UDI: (01) 00842000100041 (10) 10312135 (11) 171024 Application Server 88-01570-0000842000100416Workstation PN 88-01430-00 Version 11.0.2 UDI: (01)00842000100416(10)11.0.2.1523(11)180809 Application Server Installation 88-01589-000084200010041600842000100751Workstation Installation PN 88-01571-00 Version 11.0.3 UDI: (01)00842000100416(10)11.0.3.1601(11)181019 Workstation Installation Version 11.1.1 UDI: (01)00842000100751(10)11.1.1(11)190724 Application Server 30-01650-00 30-01654-00Workstation - Amount recalled
- 62 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Merge Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.