Recall Z-1885-2020 ยท FFK Lithotriptor, Electro-Hydraulic
Northgate Technologies, Inc.
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
| Date | Mar 24, 2020 (initiated Mar 10, 2020) |
| Status | Terminated |
| Reason | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| Root cause | Nonconforming Material/Component |
| Action | Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form". |
| Quantity | 1238 boxes. 3 units per box. |
| Distribution | US Nationwide distribution. No governmental. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc., Jan 7, 1992 |