FDA Device recall Z-1045-2017
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and ana…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and ana… by Dicom Grid, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1045-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Dicom Grid |
| Distribution | AZ, CA, CO, CT, FL, GA, HI, IL, KS, MA, MD, MI, MN, MO, NE, NH, NJ, NV, NY, OH, PA, PR, TX, UT, VA, WA, WI |
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.
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2017%22
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