The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2661-2023·Announced 2023-10-11

Medical Navigation System Recalled for Manufacturing and Electromagnetic Compatibility Defects

Olympus Veran percutaneous navigation systems are recalled due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence, affecting approximately 9,961 units distributed worldwide.

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 medical device with manufacturing and electromagnetic compatibility non-conformances. No illnesses, injuries, or actual device failures have been reported; the hazard is theoretical. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Veran percutaneous navigation systems and associated instruments, including the ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and related navigation instruments. The recall involves approximately 9,961 units distributed worldwide, including throughout the United States.

The recall is due to manufacturing non-conformances to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). Electromagnetic compatibility is the ability of electrical equipment to function acceptably without interference and to not interfere with other devices in its operating environment.

These navigation systems are used for image-guided percutaneous medical procedures. If electromagnetic compatibility is inadequate, the systems may not function properly in certain electromagnetic environments, potentially affecting procedure accuracy and patient safety.

Users should contact Olympus Corporation of the Americas for information and instructions regarding this recall.

The recalled product

Product
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Navigation System / Surgical Guidance
Hazard
Affected units
9,961

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 (7)

  • Model-UDI: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm
  • 5/Bx (includes INS-5028)" 00815686021122
  • INS-5611 SPiN Perc¿ Localization Needle - 2cm
  • 5/Bx 00815686021146
  • INS-5610 SPiN Perc¿ Localization Needle - 1cm
  • 5/Bx 00815686021139
  • INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit

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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