Device product
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Z-0986-2015
Product summary
- Event
- Event 70093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3625
- Official record key
device-enforcement:Z-0986-2015
Official wording
Reason: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Code information: Part number: SC-0014 All lots at time of notice 6/16/2013
Distribution pattern: US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Derived failure modes
-
Unknown
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.