CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report

ND: YAG Laser applicator for Ellipse Multiflex Medical recalled

Ellipse A/S is recalling Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products, distributed nationwide in the US. The recall was initiated on 5 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalledUS - 14

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1697-2016
FDA event ID: 74189
Recalling firm: Ellipse A/S, Horsholm, N/A
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2016
FDA classified: 9 Jun 2016
Reported: 15 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

5 May 2016	Recall initiated by company
9 Jun 2016	Classified by FDA	+35 days
15 Jun 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.

Where it was distributed

Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

Nationwide Arizona California Colorado Connecticut Florida Michigan Missouri New Hampshire New Jersey New York Oklahoma Pennsylvania

Questions about this recall

Is ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products recalled?

Yes. Ellipse A/S recalled ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products on 5 May 2016. The recall is Class II and its status is Terminated. Recall number Z-1697-2016.

Why was it recalled?

Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

Which lots are affected?

All serial numbers

Where was it sold?

Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ellipse A/S

All 2

Reported	Class	Recall	Company	Reason	Where
15 Jun 2016Device	CLASS II	ND: YAG Laser applicator for Ellipse Nordlys system Medical recalled	Ellipse A/S	Device Malfunction	Nationwide

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