The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2046-2013·Announced 2013-09-04

Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling

Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall involves a software labeling error where left eye images may be saved as right eye images. This is a minor labeling error with no reported injuries or illnesses, fitting the criteria for a Moderate severity score.

Plain-English summary

Nidek Inc is recalling NAVIS-EX, Image Filing Software for NIDEK AFC Fundus camera, versions 1.1.0 through 1.3.5. The software is indicated for use as file management software for ophthalmic images. The recall involves 86 units distributed nationwide in the United States.

The recall is being issued because, under certain circumstances, the left eye image may be saved as the right eye image. This error could result in incorrect labeling of patient ophthalmic records.

Consumers and healthcare providers should contact Nidek Inc for information on corrective actions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Manufacturer
Nidek Inc
Category
Medical Device — Ophthalmic Software
Hazard
Affected units
86

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 (5)

  • version 1.1.0
  • version 1.2.1
  • serial numbers 320740 120045
  • Version 1.3.4
  • 321035 321020 320998 141453

Distribution

Distributed nationwide across the United States.

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