Z-1182-2016 Class II Terminated
FDA device recall Z-1182-2016 was initiated by Mckesson Medical Immaging on February 18, 2016 and is designated Class II. Reason for recall: McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for … The recall status is terminated (terminated August 28, 2018). Affected quantity: 631 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- February 18, 2016
- Termination Date
- August 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 631 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia