Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
This recall has been terminated (originally issued June 25, 2018).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- June 25, 2018
- Terminated
- February 26, 2019
- Recall Number
- Z-2659-2018
- Quantity
- 123 devices total
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Recall is due to a design weakness of the power insert module.
Distribution
United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan
Lot / Code Info
US: 90116001, 30118001, 51215001, 201117001, 30916001, 270216001, 100917001, 31117001, 00817001, 0316001, 31217001, 180118001, 200218001, 151217001, 21217001, 21214001, 80218001, 170118001, 01017002, 101017001, 170915001, 150117001, 150217001, 291117001, 260517001, 300915001, 0318001, 30318001, 100915001, 310717001, 140716001, 50516001, 281116001, 300517001, 0316001, 30115001, 200617001, 190117001, 170117001, 241217001, 261217001, 271217001, 90118001, 0617001, 250118001, 280115001, 191015001, 81117001, 150617001, 120417001, 140917001, 10318001, 140417001, 250717001, 80518001, 160616001, 170417001, 150417001, 11116001, 91017001, 81117002, 281117001, 20218001, 300118001, 131015001, 140318001, 110516001, 00318001, 160118001, 30518001, 200316001, 120917001, 210118001, 310717001, 30218001, 1217001, 190617001, 130617001, 280817001, 80317001, 310817001, 10917001, 60317001, 60218001, 80917001 230318001, 170318001; Puerto Rico: 241216001, 261216001; JAPAN: 140717001,171017001, 211117001, 291217001, 290118001, 210218001, 280218001, 020318001, 120318001, 160318001; BRAZIL: 120416001, 220917001, 311017001, 70118001, 70318001; COLOMBIA: 60517001; ECUADOR: 170316001, 231216001, 190917001; MEXICO: 31215001, 130117001, 91217001; TAIWAN: 190815001, 220317001, 190317001, 40517001, 210717001, 210717002, 211217001
Root Cause
Device Design
Action Taken
Leica Microsystems notified customers on about 06/25/2018 via URGENT FIELD SAFETY NOTICE letter. Instructions included advising customers of the issue, informing them that Leica Microsystems representative will contact them to arrange the fiel update to the device, distribute the recall notification to all individuals that should be aware of the recall or if the device was further distributed and a response form was provided to complete and return. The notification letter also instructed customers to report any anomalies with the system to Leica Microsystems if they occur prior to the correction being made and to ensure a functional check is performed prior to each surgery as described in the user manual.