Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1045-2017·Announced 2017-01-25

DICOM GRID Recalls Ambra PACS Software Due to Image Display Error

DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect affects image quality (washed-out appearance) but no specific injuries or illnesses are reported in the source text, fitting the Moderate criteria for a software defect without reported harm.

Plain-English summary

DICOM GRID Inc. is recalling 209 units of Ambra PACS software, version V3.16.13.0, under FDA recall number Z-1045-2017. The software is intended for use as a primary diagnostic and analysis tool for diagnostic images.

The recall is due to a software error that causes the window and level settings to become identical across a series of images, regardless of the actual image levels. This defect results in the images having a washed-out grey appearance, which may compromise the diagnostic utility of the software.

The affected software was distributed in the United States to facilities in Texas, Florida, Nebraska, California, Wisconsin, Arizona, New Hampshire, Missouri, Massachusetts, Colorado, Pennsylvania, Nevada, Puerto Rico, Illinois, Ohio, New York, Maryland, New Jersey, Minnesota, Michigan, Connecticut, Virginia, Georgia, Utah, Kansas, Washington, and Hawaii. It was also distributed in Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, and Australia. Users of this specific software version should contact DICOM GRID Inc. for further instructions regarding the recall.

The recalled product

Product: 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.
Manufacturer: DICOM GRID INC
Category: Medical Device — Software
Hazard: software-defect
image-quality
Affected units: 209

Distribution

Distributed in 27 states:

Same manufacturer · DICOM GRID INC

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