Recall Z-1697-2016— Ellipse A/S

Name: FDA recall Z-1697-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Class II · Terminated

Class II FDA medical device recall by Ellipse A/S, initiated 2016-05-05, terminated 2016-07-29. It names one FDA 510(k) clearance: K140670. Product: Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.. Reason: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system..

Recalling firm: Ellipse A/S
Classification: Class II
Status: Terminated
Initiated: 2016-05-05
Terminated: 2016-07-29
Firm location: Horsholm, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K140670 — ELLIPSE I2PL+/ELLIPSE MULTIFLEX+Ellipse A/S·cleared 2014-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.