Device product
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25" Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2" x 2.25" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
Z-0816-2013
Product summary
- Event
- Event 63927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25860 electrodes
- Official record key
device-enforcement:Z-0816-2013
Official wording
Reason: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Code information: All Serial Numbers distributed between 11/01/2009 and 01/31/2010
Distribution pattern: Distributed in the states of GA and TN.
Derived failure modes
-
Unknown
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.