Ellex Super Q LQP3106 ophthalmic laser
FDA device recall Z-1840-2011 · posted 2011-04-12 · Terminated
Recall details
- Recalling firm
- Ellex Medical Pty Ltd
- Reason for recall
- Unintended laser emission while the user was moving the joystick for targeting.
- Action taken
- 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
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 814 units
- Distribution
- worldwide distribution
- Date initiated
- 2011-02-15
- Date posted
- 2011-04-12
- Date terminated
- 2012-10-02
- Location
- Adelaide, Australia
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