Health product recall

Provido, Proveo 8 and M530 OHX Microscopes

Last updated

Summary

Product
Provido, Proveo 8 and M530 OHX Microscopes
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected Products

Lot or serial number

Model or catalog number

M530 OHX – Optics Carrier

10448737

291122001
11221001
281122001
140223001
60422002
140222002
301122002
230822001

Leica Proveo 8 Ophthalmic Microscope System

10449058

More than 10 numbers, contact manufacturer.

Provido

10448976
10448950

110722001
130722001
140722001

Issue

Complaint trending revealed an adverse trend of complaints stating that a LMS surgical operating microscope unexpectedly shut down caused by a defective 24VDC power supply which is used inside the surgical operating microscopes Provido, Proveo 8 and M530 OHX. Based on the results of the investigations there is a reasonable probability that the MOSFET in the power supply unit of these microscopes will overheat and become defective.

Recall Start Date: August 30, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - General and plastic surgery
Companies

Leica Microsystems (Schweiz) Ag

Max Schmidheiny-Strasse 201, Heerbrugg, St. Gallen, Switzerland, 9435

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74338

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