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Terminated

Ellex Ultra Q LQP3106-U ophthalmic laser

FDA Recall Z-1841-2011 · Posted 2011-04-12

Recalling FirmEllex Medical Pty Ltd
Recall StatusTerminated
Product CodeHQF
Date Initiated2011-02-15
Date Terminated2012-10-02
Product Quantity233 units

Reason for Recall

Unintended laser emission while the user was moving the joystick for targeting.

Firm Action

Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.

Root Cause

Process control

Distribution Pattern

worldwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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