Device product
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Z-0073-2018
Product summary
- Event
- Event 77367
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186
- Official record key
device-enforcement:Z-0073-2018
Official wording
Reason: The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
Code information: Model No. 9-195-371DS, Lot/Serial Number LDS12516
Distribution pattern: US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Derived failure modes
-
Labeling or packaging
mislabeled