Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming
Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.
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: The recall involves a medical device where a software error could lead to unintended treatment, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12, which are PC-based software installed outside the Nidek EC-5000 Excimer Laser System. The system is an ophthalmic laser used for the correction of corneal refraction and ablation of the corneal surface. The recall involves 29 units distributed nationwide to facilities in Minnesota, Nevada, Ohio, North Carolina, California, Colorado, Georgia, Virginia, Michigan, Arizona, Pennsylvania, Tennessee, Washington, Texas, and New York.
The recall was initiated because, during treatment planning, the procedure was programmed with an unintended (wrong) correction. This software defect could lead to incorrect treatment parameters being applied to patients.
Facilities that have installed Final Fit Software versions 1.11 or 1.12 should contact Nidek Inc for further instructions on how to resolve the issue. The specific serial numbers of the affected devices are listed in the official recall documentation.
The recalled product
- Product
- Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which…
- Manufacturer
- Nidek Inc
- Affected units
- 29
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)
- Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009
- NVE0002
- OH00295
- NC00185
- CAE0016
- COE0008
- MI00131
- GA00241
- CAE0007
- VAE0004
- CAE0031
- AZ00167
- COE0011
- CA00561
- PAE0003
- TN00168
- MNE0009
- WA00246
- CAE0047
- OHE0005
Distribution
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