FDA Medical Device Recalls (openFDA)
Ziemer Usa Inc: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
- Recall number
- Z-0988-2015
- Recalling firm
- Ziemer Usa Inc
- Product
- Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
- Status
- Terminated
- Initiated
- 2014-12-18
- Posted
- 2015-01-15
- Terminated
- 2018-02-20
- Reason
- The devices were not shipped with the Starter Kits.
- Root cause
- Labeling False and Misleading
- Action
- Notification letters dated December 18, 2014 were sent to all direct account s(customers). The letters were included with the Starter Kit referred to in the Surgical Procedure Manual.
- Quantity
- 26 lasers
- Distribution
- US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
- Lot, serial or model codes
- Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776
- 510(k) numbers
- ["K131207"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 3006231532
- Firm city
- Alton
- Firm state
- IL
- Firm country
- not on file
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