Device product
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
Z-1268-2021
Product summary
- Event
- Event 87443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11400 devices
- Official record key
device-enforcement:Z-1268-2021
Official wording
Reason: The mirror may become detached and fall from the unit
Code information: All lot numbers
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.
Derived failure modes
-
Unknown
The mirror may become detached and fall from the unit