Device product
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Z-2679-2020
Product summary
- Event
- Event 85815
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193 devices
- Official record key
device-enforcement:Z-2679-2020
Official wording
Reason: The needle surface deteriorated due to unexpected electrolysis during procedure.
Code information: UPN:FPRPR3606, GTIN: 7290104831041, Batch: A1148, A1171, A1248, A1460, A1561, A1582, A1936, A2121, A6702, A6743, A6856, A6925, A7013, A7026, A7088, A7148, T0054, T0136, T0141, T0224, T0236, T0237, T0268, T0437, T0592, U0082, U0027, U0093, U0226, U0227
Distribution pattern: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
Derived failure modes
-
Unknown
The needle surface deteriorated due to unexpected electrolysis during procedure.