Z-0477-2023 Class II Ongoing
FDA device recall Z-0477-2023 was initiated by Leica Microsystems, Inc. on November 21, 2022 and is designated Class II. 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, on… The recall status is ongoing. Affected quantity: 148 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- November 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 units
Product Description
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
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.
Distribution Pattern
US Nationwide
Code Information
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.