Recall Z-0333-2022 ยท FFK Lithotriptor, Electro-Hydraulic
Northgate Technologies, Inc.
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
| Date | Oct 25, 2021 |
| Status | Open, Classified |
| Reason | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. |
| Root cause | Software design (manufacturing process) |
| Action | The recalling firm, Northgate Technologies Inc., issued a recall letter dated 10/25/2021 to their customer explaining the reason for recall. The customer was requested to determine the location of the affected devices. If the device is/could be used in one of the affected languages, the device is to be returned so the software can be updated to address the text mix-up. If the device is not or will not be operated in the affected languages, the device does not need to be returned immediately and the software will be upgraded during the next servicing to address the mix-up. Complete the encl |
| Quantity | 2,277 devices |
| Distribution | US Distribution to state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130368 | AUTOLITH TOUCH; URO TOUCH Northgate Technologies, Inc., Nov 15, 2013 |