Medical device recalls Moderate risk

Ziemer Usa Inc recalls Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

Recall date
December 18, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0988-2015
FDA classification
Class II
Brand / firm
Ziemer Usa Inc
Sold / distributed
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)

Why it was recalled

The devices were not shipped with the Starter Kits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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