Z-0279-2019 Class II Terminated
FDA device recall Z-0279-2019 was initiated by Medtronic Navigation, Inc.-Littleton on August 30, 2018 and is designated Class II. Reason for recall: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a… The recall status is terminated (terminated June 18, 2020). Affected quantity: 596 total.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- August 30, 2018
- Termination Date
- June 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 596 total
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Venezuela.