DICOM GRID INC recalls Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R S
See all recalls from DICOM GRID INC →Recalled Product
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+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.
Hazard / Issue
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.
Issued by
FDA
Affected States: TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, HI
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Ambra PACS →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime