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Recall Observatory FDA recall evidence

Device product

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

Z-0988-2015

December 18, 2014

Class II

Product summary

Firm
Ziemer Usa Inc
Event
Event 70024
Status
Terminated
Classification
Class II
Quantity
26 lasers
Official record key
device-enforcement:Z-0988-2015

Official wording

Reason: The devices were not shipped with the Starter Kits.

Code information: 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

Distribution pattern: US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The devices were not shipped with the Starter Kits.