FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
- Recall number
- Z-2659-2018
- Recalling firm
- Leica Microsystems, Inc.
- Product
- Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
- Status
- Terminated
- Initiated
- 2018-06-25
- Posted
- not on file
- Terminated
- 2019-02-26
- Reason
- Recall is due to a design weakness of the power insert module.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 123 devices total
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3000210133
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28