Z-0715-2018 Class II Terminated
FDA device recall Z-0715-2018 was initiated by Mobius Imaging, LLC on September 26, 2017 and is designated Class II. Reason for recall: If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup o… The recall status is terminated (terminated August 16, 2018). Affected quantity: 105.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- September 26, 2017
- Termination Date
- August 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan