Z-0988-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- December 18, 2014
- Termination Date
- February 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 lasers
Product Description
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Reason for Recall
The devices were not shipped with the Starter Kits.
Distribution Pattern
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
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