Quick summary
Quick summary: Provido, Proveo 8 and M530 OHX Microscopes. Date: 2023-09-28.
Public recall detail
Provido, Proveo 8 and M530 OHX Microscopes
2023-09-28
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Provido, Proveo 8 and M530 OHX Microscopes. Date: 2023-09-28.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandLeica Microsystems Schweiz AG
ProductProvido, Proveo 8 and M530 OHX Microscopes
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74338
Affected products
ProductM530 OHX – Optics Carrier
Lot10448737
Model291122001 11221001 281122001 140223001 60422002 140222002 301122002 230822001
Serial number10448737
DescriptionM530 OHX – Optics Carrier
ProductLeica Proveo 8 Ophthalmic Microscope System
Lot10449058
ModelMore than 10 numbers, contact manufacturer.
Serial number10449058
DescriptionLeica Proveo 8 Ophthalmic Microscope System
ProductProvido
Lot10448976 10448950
Model110722001 130722001 140722001
Serial number10448976 10448950
DescriptionProvido
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices Health products - Medical devices - Ear, nose and throat Health products - Medical devices - General and plastic surgery
CompaniesLeica Microsystems (Schweiz) Ag Max Schmidheiny-Strasse 201, Heerbrugg, St. Gallen, Switzerland, 9435
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74338
Background{}
CompaniesLeica Microsystems (Schweiz) Ag Max Schmidheiny-Strasse 201, Heerbrugg, St. Gallen, Switzerland, 9435
AudiencesHealthcare
Source updated2023-09-28
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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