Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0811-2014 — 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO

U.S. FDA — Device Enforcement · United States · 2013-04-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0811-2014
Date of alert: 2013-04-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ziemer Usa Inc
Product category: device
Product type: Devices

Reported risk: A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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