Ellipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions
Ellipse A/S is recalling 14 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) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation error.
Plain-English summary
Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators used with Ellipse Multiflex Medical Laser Products. 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. All serial numbers are included in this recall.
Consumers and healthcare facilities should contact Ellipse A/S for further instructions on how to proceed with the recall.
The recalled product
- Product
- Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
- Manufacturer
- Ellipse A/S
- Category
- Medical Device — Laser Equipment
- Affected units
- 14
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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