Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AUTOLITH TOUCH Bipolar Electrohydraulic Lit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall AUTOLITH TOUCH Bipolar Electrohydraulic Lit see related information
Date Initiated by Firm October 25, 2021
Create Date December 03, 2021
Recall Status1 Open3, Classified
Recall Number Z-0333-2022
Recall Event ID 88944
510(K)Number K130368  
Product Classification Lithotriptor, electro-hydraulic - Product Code FFK
Product 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.
Code Information All serial number revisions for the following bracketed base serial numbers distributed between 2/14/2017 and 10/7/2021: 21578LAA to 21627LAA 21628BBA to 21662BBA 21667CBA to 21689CBA; 21691CBA to 21697CBA; 21699CBA to 21716CBA 21690CBA, 21698CBA, 21721DBA to 21732DBA; 21734DBA to 21747DBA; 21749DBA to 21756DBA; 21758DBA to 21763DBA; 21765DBA to 21770DBA 21733DBA, 21748DBA, 21757DBA, 21764DBA, 21771EBA to 21781EBA; 21783EBA to 21787EBA; 21789EBA, 21790EBA, 21792EBA to 21800EBA; 21804EBA to 21820EBA 21782EBA, 21788EBA, 21791EBA, 21801EBA to 21803EBA; 21821FBA to 21874FBA 21883HBB to 21942HBB 21954IBB to 22025IBB 22026IBB to 22073IBB 22074IBB to 22130KBB; 22133KBB 22131KBB 22134LBB to 22157LBB 22158ACB to 22229ACB 22230ACB to 22249ACB 22250BCB to 22321BCB 22322CCB to 22393CCB 22394CCB to 22441CCB 22453ECB to 22476ECB 22477FCB to 22488FCB 22489GCB to 22500GCB 22511HCB to 22534HCB 22535ICB to 22558ICB 22559JCB to 22564JCB; 22570JCB to 22575JCB 22566JCB to 22569JCB; 22576JCB, 22577JCB, 22579JCB, 22581JCB to 22585JCB 22565JCB, 22578JCB, 22580JCB, 22586JCB to 22588JCB; 22590JCB to 22593JCB; 22595JCB, 22598JCB 22597JCB, 22600JCB to 22603JCB; 22607JCB to 22609JCB; 22611JCB, 22614JCB, 22615JCB, 22623JCB 22589JCB, 22594JCB, 22596JCB, 22599JCB, 22604JCB, 22606JCB, 22610JCB, 22612JCB, 22613JCB, 22616JCB to 22618JCB 22605JCB, 22619JCB to 22622JCB; 22624JCB to 22630JCB 22637KCB, 22638KCB, 22640KCB to 22666KCB; 22669KCB, 22671KCB to 22637KCB; 22677KCB, 22678KCB, 22680KCB 22636KCB, 22639KCB, 22639KCB to 22668KCB; 22670KCB to 22676KCB; 22679KCB, 22681KCB to 22707KCB 22632KCC to 22635KCC; 22708LCC to 22751LCC 22752ADC to 22799ADC 22800BDC to 22895BDC 22896CDC to 22943CDC 22944EDC to 22991EDC 22992FDC to 23039FDC 23040GDC to 23087GDC 23088IDD to 23135IDD 23136JDD to 23183JDD 23184KDD to 23231KDD 23232LDD to 23279LDD 23280AED to 23327AED 23328CED to 23375CED 23376DED to 23406DED; 23408DED to 23413DED; 23415DED, 23416DED, 23419DED, 23420DED, 23432DED, 23436DED to 23441DED 23407DED, 23414DED, 23417DED, 23418DED; 23421DED to 23431DED; 23433DED to 23435DED; 23442DED to 23471DED 23472HED to 23519HED 23520IED to 23567IED 23568KED to 23615KED 23616AFD to 23627AFD 23628AFD to 23663AFD 23664CFE to 23711CFE 23712DFE to 23759DFE 23760EFE to 23807EFE 23808GFE to 23855GFE 23856HFE to 23867HFE 23868IFE to 23879IFE 23880IFE to 23894IFE; 23896IFE to 23899IFE; 23902IFE to 23904IFE; 23907IFE, 23908IFE GTIN 00817183020493, UDI 00817183020493.
Recalling Firm/
Manufacturer		 Northgate Technologies, Inc.
1591 Scottsdale Ct
Elgin IL 60123-9361
For Additional Information Contact Ms. Laura MacMillian
800-348-0424
Manufacturer Reason
for Recall		 The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
FDA Determined
Cause 2		 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 enclosed Recall Acknowledgment Form indicating the serial numbers, distribution dates, and whether the device needs correction now or later and email it to: customerservice@ntisurgical.com. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. If you have any questions, please contact me at (224) 856-2250 or by e-mail, tgatto@ntisurgical.com.
Quantity in Commerce 2,277 devices
Distribution US Distribution to state of MA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FFK and Original Applicant = NORTHGATE TECHNOLOGIES INC.
-
-