FDA Medical Device Recalls (openFDA)
Ellex Medical Pty Ltd: Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
- Recall number
- Z-1843-2011
- Recalling firm
- Ellex Medical Pty Ltd
- Product
- Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
- Status
- Terminated
- Initiated
- 2011-02-15
- Posted
- 2011-04-12
- Terminated
- 2012-10-02
- Reason
- Unintended laser emission while the user was moving the joystick for targeting.
- Root cause
- Process control
- Action
- Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.
- Quantity
- 679 units
- Distribution
- worldwide distribution
- Lot, serial or model codes
- Units manufactured between August 2007 and 20 February 2011.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 3002806902
- Firm city
- Adelaide
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28