CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

Ambra PACS recalled by Dicom Grid

Dicom Grid is recalling Ambra PACS, distributed in 27 states. The recall was initiated on 16 Dec 2016 and the FDA has classified it as Class II.

Recall details

Recall number: Z-1045-2017
FDA event ID: 76187
Recalling firm: Dicom Grid, Phoenix, AZ
Classification: Class II
Status: Terminated
Recall initiated: 16 Dec 2016
FDA classified: 18 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

16 Dec 2016	Recall initiated by company
18 Jan 2017	Classified by FDA	+33 days
25 Jan 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

A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

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

Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

Where it was distributed

U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.

Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Kansas Massachusetts Maryland Michigan Minnesota Missouri Nebraska New Hampshire New Jersey Nevada New York Ohio

Questions about this recall

Why was it recalled?

A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

Where was it sold?

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.

More recalls from Dicom Grid

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Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	Intelerad InteleShare recalled by DICOM Grid	Dicom Grid	Labeling Errors	44 states
5 Oct 2022Device	CLASS II	Ambra PACS, Ambra ProViewer recalled by DICOM Grid	Dicom Grid	Device Malfunction	43 states

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