Recall Z-0476-2023— Leica Microsystems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2022-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system. Reason: 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..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-21
- Firm location
- deerfield, IL, United States
Product description
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.