The Recall Desk
HighFDA (Devices)·Z-0476-2023·Announced 2022-12-21

Leica Provido surgical microscope models at risk of unexpected power shutdown

Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a surgical microscope system with a specific risk-of-harm issue—unexpected shutdown during use could disrupt patient care. No illnesses or injuries reported in source. Fits rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Leica Microsystems, Inc. is recalling 38 units of the Provido surgical microscope system (part numbers 10448950 Premium and 10448976 Standard) distributed nationwide in the United States. The affected systems contain a potential power supply defect.

The power supply's internal components may overstress and overheat. When this occurs, one specific component can fail, causing the device to unexpectedly shut down without warning during use.

Affected units have specific serial numbers documented in the FDA recall notice. Users should verify their system's serial number and contact Leica Microsystems, Inc. for service, repair, or replacement instructions.

Healthcare facilities and surgical centers using affected units should identify them immediately using the provided serial numbers and take the devices out of service until repairs are completed.

The recalled product

Product
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Manufacturer
Leica Microsystems, Inc.
Category
Medical Device — Surgical Microscope
Hazard
Affected units
38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950
  • Serial Numbers: 160222001
  • 280622001
  • 50422001
  • 50422002
  • 91221001
  • 180622001
  • 170622001
  • 61221001
  • 130922001
  • 120623001
  • 150623001
  • 81022001
  • 200623001
  • 51022001
  • 61022001. b. Standard Part Number 10448976
  • Serial Numbers: 120322001
  • 300122001
  • 40222002
  • 301221001

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Leica Microsystems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Leica Microsystems, Inc.

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