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Terminated

Model LightLas 532 Opthalmic Photocoagulator Laser

FDA Recall Z-0228-04 · Posted 2003-12-17

Recalling FirmLightMed USA Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2003-11-11
Date Terminated2003-12-16
Product Quantity2

Reason for Recall

Firm needed to include calibration procedures in user guide.

Firm Action

Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.

Root Cause

Other

Distribution Pattern

CA, GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010372LIGHTLAS 532 PHOTOCOAGULATORLightmed Corp. · 2001-08-22K990075LPULSA SYL-9000 OPHTHALMIC YAG LASERLight-Med(Usa), Inc. · 1999-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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