The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2659-2023·Announced 2023-10-11

Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance

Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 without reported illnesses or injuries. The EMC non-conformances and manufacturing defects create a risk of device malfunction during surgical guidance, meeting the rubric criterion for High severity where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling multiple models of the SPiN Thoracic Navigation System and related navigation instruments, including the ig4 Image Guided System and SPiN Planning Laptop Workstation. The recall affects 226 units distributed worldwide, including the United States and internationally in China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The devices are being recalled due to non-conformances in manufacturing that do not meet design requirements, combined with insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment to function acceptably without interference and to not interfere with other devices in its operating environment. These deficiencies could affect the device's ability to function reliably during thoracic surgical guidance procedures.

No illnesses or injuries have been reported to date. Affected healthcare facilities should cease use of these systems and contact Olympus Corporation of the Americas for instructions regarding replacement, repair, or return of the affected equipment.

The recalled product

Product
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Navigation System
Hazard
Affected units
226

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)

  • Model-UDI: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz 00815686020118
  • SYS-4000 SPiN Thoracic Navigation System 00815686020101
  • SYS-3230 ig4 System
  • 230V
  • 50Hz / SPiN Thoracic Navigation System 00815686020095
  • SYS-3000 SPiN Thoracic Navigation System 00815686020088
  • SYS-2400 SPiN Drive System N/A
  • SYS-2230 ig4 System V2
  • 50Hz 00815686020071
  • SYS-2000 ig4 Image Guides System 00815686020064
  • SYS-1500 SPiN View" System 00815686020057
  • SYS-1000 ig4 Image Guides System N/A
  • SYS-0220 ig4 System
  • 220V
  • 50Hz N/A
  • SYS-0185 SPiN Planning Laptop Workstation 00815686020033
  • SYS-0128 Planning Workstation w/Monitor N/A
  • SYS-0002 ig4 System N/A
  • INS-7150 SPiN Vision Scope Adapter N/A
  • All serial numbers and all lot numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Olympus Corporation of the Americas 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 6 products in this recall →

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