Z-1665-2014 Class II Terminated
FDA device recall Z-1665-2014 was initiated by GE Healthcare on Apr 3, 2014 and is designated Class II. Reason for recall: It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed… The recall status is terminated (terminated Jun 5, 2015). Affected quantity: 297 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 4, 2014
- Initiation Date
- Apr 3, 2014
- Termination Date
- Jun 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV, and the countries of Australia, Canada, Chile, France, Germany, India, Ireland, Israel, Italy, Japan, Korea (South), Kuwait, Lebanon, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1665-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026