Z-0116-2014 Class II Terminated
FDA device recall Z-0116-2014 was initiated by GE Healthcare It on June 11, 2013 and is designated Class II. Reason for recall: GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centr… The recall status is terminated (terminated June 10, 2016). Affected quantity: 623 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- June 11, 2013
- Termination Date
- June 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 623 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia.