Z-0477-2023Class II

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Name: Z-0477-2023 Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Creator: Leica Microsystems, Inc.
Published: 2022-11-21
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2022-11-21 / Open, Classified / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system on 2022-11-21. FDA classified it as Class II and gives the reason as "There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0477-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-21
Posted: 2022-12-09
Recalling firm: Leica Microsystems, Inc.
Product: Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Product code: EPT Microscope, Surgical
Reason for recall: There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issued an URGENT FIELD SAFETY NOTICE to its consignees by email on 11/21/2022. The notice explained the issue and stated that a Leica Microsystems representative would be contacting each facility to arrange an update to the the affected devices and advised the following: Consignees can continue to use the system pending the field update; Ensure that all users of the affected microscope are aware of the Safety notes as described in section 3 of the respective user manual; Like any other instrument in the operating theater, the system may fail and Leica Microsystem (Schweiz) AG recommends that a backup system be kept available during the operation; Check before the operation : Connect the power cable. + Switch on the microscope. UPDATE 09/12/2023: Recall was expanded, and customers were sent the notification on about 09/11/2023. Each consignee is requested to acknowledge receipt of the Field Safety Notice letter outlining the potential manufacturing defect, perform an initial inspection, indicate the results of the initial inspection, and provide contact information for further Leica Microsystems Representative verification of conformity/defect.
Quantity in commerce: 148 units
Distribution: US Nationwide
Product codes and lots: Serial Numbers: 10622001, 10622002, 10822001, 20322002, 20522001, 20622001, 30122001, 30322001, 30522001, 30622002, 30722001, 31221001, 40422001, 41221001, 50122001, 60122001, 60522001, 60622001, 70122001, 70322001, 70422001, 70622001, 80422001, 80422002, 80722001, 80822001, 90122001, 90622001, 91221001, 100122001, 100122002, 100322002, 100622001, 100622002, 110222001, 110522001, 110822001, 111221001, 120222001, 120522001, 130122001, 130522001, 130622001, 140122001, 140222001, 140422001, 140522001, 141221001, 151221001, 160122001, 160322001, 160622001, 160622002, 170222001, 170522001, 190322001, 190622001, 200122001, 200522001, 200722001, 210422001, 210622001, 230222001, 230622001, 240122001, 240522001, 260522001, 260722001, 260722002, 261121001, 261221001, 270122001, 270422001, 270422002, 270522001, 270622001, 271121001, 280222002, 280622001, 290522001, 290622001, 291221001, 300322001, 300622002, 301121001, 301221001, 310322001, 310522001. ***EXPANSION 09/08/2023, Serial Numbers: 220523002, 220822001, 131222001, 251122001, 271122001, 100223001, 220423001, 300822001, 30323001, 41222001, 51222001, 91222002, 81222002, 301122001, 180822001, 71222001, 180722001, 220523001, 300523002, 80623001, 30523001, 11122001, 31122001, 81122001, 91222001, 30723001, 211122001, 121222001, 310523001, 40423001, 290323001, 300323001, 141222001, 141222002, 310822001, 40623002, 300922001, 200223001, 90223001, 180523001, 280523001, 240423001, 10623001, 191122001, 61222001, 90623001, 190423001, 70223001, 90223002, 40723001, 130623001, 180423001, 230922001, 260922001, 251022001, 291022001, 200323001, 261022001, 140523001, 160523001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0476-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0477-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09

Product code EPT

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)