Z-1045-2017Class II

Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use...

Name: Z-1045-2017 Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use...
Creator: Dicom Grid Inc
Published: 2016-12-16
License: https://open.fda.gov/license/

DICOM Grid (dba Ambra Health) / initiated 2016-12-16 / Terminated / root cause: software

FDA source

DICOM GRID INC began a recall of 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... on 2016-12-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1045-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-01-18
Terminated: 2017-04-07
Recalling firm: DICOM Grid (dba Ambra Health)
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action.
Quantity in commerce: 209
Distribution: 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.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1045-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

Product code LLZ

K152977Class IIDg PacsDicom Grid, Inc. / cleared 2016-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)