Z-2659-2018Class II

Leica M530 OHX Microscope System Supplied with 100 - 120 Vac

Name: Z-2659-2018 Leica M530 OHX Microscope System Supplied with 100 - 120 Vac
Creator: Leica Microsystems, Inc.
Published: 2018-06-25
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2018-06-25 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Leica M530 OHX Microscope System Supplied with 100 - 120 Vac on 2018-06-25. FDA classified it as Class II and gives the reason as "Recall is due to a design weakness of the power insert module". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2659-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-25
Posted: 2018-08-07
Terminated: 2019-02-26
Recalling firm: Leica Microsystems, Inc.
Product: Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Reason for recall: Recall is due to a design weakness of the power insert module.
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2659-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2659-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-07

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)