FDA Device recall Z-2678-2020
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are…
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are… by Boston Scientific, citing the needle surface deteriorated due to unexpected electrolysis during procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2678-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-04 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Ablation Galil Technology, IceFORCE 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.
Reason
The needle surface deteriorated due to unexpected electrolysis during procedure.
Identifiers
| code_info | UPN: FPRPR3605, GTIN: 7290104831034, Batch: A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, T0153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2678-2020%22
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