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Terminated

GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079

FDA Recall Z-2502-2010 · Posted 2010-09-25

Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2010-01-22
Date Terminated2011-01-25
Product Quantity11668 units

Reason for Recall

Product may be packed with incorrect external or internal labels and/or missing product insert.

Firm Action

Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESLaserscope · 2006-12-01

Official Source

View FDA Recall →

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

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