CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report

iConnect Enterprise Archive when used with RadSuite recalled

Merge Healthcare is recalling iConnect Enterprise Archive when used with RadSuite, distributed nationwide in the US. The recall was initiated on 4 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesiConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.

Quantity recalled187 sites potentially have the affected versions

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-1470-2017
FDA event ID: 76654
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2016
FDA classified: 15 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Apr 2016	Recall initiated by company
15 Mar 2017	Classified by FDA	+345 days
22 Mar 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

Where it was distributed

USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

Nationwide

Questions about this recall

Why was it recalled?

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

Which lots are affected?

iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.

Where was it sold?

USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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