DICOM GRID INC: Medical Device Recall in 2017 - (Recall #: Z-1045-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 16, 2016

Date Posted: January 25, 2017

Recall Number: Z-1045-2017

Event ID: 76187

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.

Status: Terminated

Product Quantity: 209

Code Information:

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated