Ellipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
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 is classified as FDA Class II, but the specific defect is a documentation issue (missing calibration instructions) rather than a direct physical hazard or reported injury, fitting the Moderate criteria for minor labeling/documentation errors.
Plain-English summary
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators used with the Ellipse Nordlys system. The recall was initiated because the products failed to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
The affected units were distributed nationwide to the states of New Jersey, Pennsylvania, Michigan, Colorado, California, Florida, Oklahoma, New York, New Hampshire, Connecticut, Arizona, and Missouri. The recall covers all serial numbers for this specific product.
Consumers and healthcare facilities should stop using the affected applicators and contact Ellipse A/S for further instructions on how to proceed.
The recalled product
- Product
- Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
- Manufacturer
- Ellipse A/S
- Hazard
- Affected units
- 25
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 (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ellipse A/S 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 2 products in this recall →Related recalls
Same manufacturer · Ellipse A/S
See all →- ModerateEllipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions
FDA (Devices) · 2016-06-15
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