Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Leica Microsystems, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Product Codes/Lot Numbers:
Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0475-2023
Related Recalls
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.
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Leica Microsystems
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.
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Leica Microsystems
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.