Recall Z-1045-2017— DICOM GRID INC

Name: FDA recall Z-1045-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Class II · Terminated

Class II FDA medical device recall by DICOM GRID INC, initiated 2016-12-16, terminated 2017-04-07. It names one FDA 510(k) clearance: K152977. 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.. Reason: 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..

Recalling firm: DICOM GRID INC
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Terminated: 2017-04-07
Firm location: Phoenix, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K152977 — DG PACSDicom Grid, Inc.·cleared 2016-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.