Recall Z-0477-2023
Leica Microsystems, Inc. · initiated November 21, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Codes / 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…
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0477-2023
- Initiated
- November 21, 2022
- Posted by FDA
- December 9, 2022
- Product code
- EPT – Microscope, Surgical
- Quantity
- 148 units
- Distribution
- US Nationwide
- Recalling firm
- Leica Microsystems, Inc., deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0475-2023 Class II | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemThere is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | 11/21/2022Open, Classified |
| Z-0476-2023 Class II | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard).…There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | 11/21/2022Open, Classified |