Z-0073-2018Class II

Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith...

Name: Z-0073-2018 Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith...
Creator: Northgate Technologies, Inc.
Published: 2017-05-24
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2017-05-24 / Terminated / root cause: labeling and UDI

FDA source

Northgate Technologies, Inc. began a recall of 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... on 2017-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0073-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-24
Posted: 2017-11-08
Terminated: 2020-06-09
Recalling firm: Northgate Technologies Inc.
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.
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.
Quantity in commerce: 186
Distribution: US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Product codes and lots: Model No. 9-195-371DS, Lot/Serial Number LDS12516

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0073-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code FFK

K914514Class II1.9 French Lithotripter Electrode, ModificationNorthgate Technologies, Inc. / cleared 1992-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)