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U.S. Department of Health and Human Services

Class 2 Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

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  Class 2 Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers see related information
Date Initiated by Firm December 18, 2014
Date Posted January 15, 2015
Recall Status1 Terminated 3 on February 20, 2018
Recall Number Z-0988-2015
Recall Event ID 70024
510(K)Number K131207  
Product Classification Laser, ophthalmic - Product Code HQF
Product Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
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
Recalling Firm/
Ziemer Usa Inc
620 East Third Street
Alton IL 62002
For Additional Information Contact Ms. Angela Braida
Manufacturer Reason
for Recall
The devices were not shipped with the Starter Kits.
FDA Determined
Cause 2
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 in Commerce 26 lasers
Distribution US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = SURGICAL INSTRUMENT ENGINEERING AG