Z-0225-2016 Class II Terminated
FDA device recall Z-0225-2016 was initiated by GE Healthcare on Sep 28, 2015 and is designated Class II. Reason for recall: Inaccurate distance measurements with magnified projection X-ray images. The recall status is terminated (terminated Apr 11, 2018). Affected quantity: Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 11, 2015
- Initiation Date
- Sep 28, 2015
- Termination Date
- Apr 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
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-0225-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026