Device product
Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Z-2681-2020
Product summary
- Event
- Event 85815
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71 devices
- Official record key
device-enforcement:Z-2681-2020
Official wording
Reason: The needle surface deteriorated due to unexpected electrolysis during procedure.
Code information: UPN:FPRPR3608, GTIN: 7290104831065, Batch: A1170, A1583, A1937, A6710, A6744, A6857, A6900, A6913, A6926, A7014, A7027, A7122, T0055, T0144, T0181, T0211, T0212, T0238, T0270, T0816, T0815
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.