CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Merge RadSuite recalled by Merge Healthcare

Merge Healthcare is recalling Merge RadSuite, distributed in Alabama, Indiana, Michigan, Pennsylvania, Wisconsin. The recall was initiated on 17 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion V8.30.7.8

Quantity recalled8 sites have the potentially affected version

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-1180-2017
FDA event ID: 76258
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2015
FDA classified: 9 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Medical Software

Timeline

17 Nov 2015	Recall initiated by company
9 Feb 2017	Classified by FDA	+450 days
15 Feb 2017	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

The values provided from the Pixel Value tool do not appear to be correct, 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

Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Where it was distributed

US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

Alabama Indiana Michigan Pennsylvania Wisconsin

Questions about this recall

Is Merge RadSuite recalled?

Yes. Merge Healthcare recalled Merge RadSuite on 17 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-1180-2017.

Why was it recalled?

The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.

Which lots are affected?

Version V8.30.7.8

Where was it sold?

US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

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.

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