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Terminated

GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.

FDA Recall Z-0130-2008 · Posted 2008-03-20

Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2007-04-17
Date Terminated2010-03-23
Product Quantity169 units

Reason for Recall

Component missing: Some products were issued without thermal protection switches.

Firm Action

AMS issued Important: Medical Device Correction letters, dated April 17, 2007, to its US and international consignees by mail, instructing them to return an acknowledgement form. The letter informs customers that some HPS systems may lack a motor overload switch, that the firm believes that there is no immediate safety issue, and installation of the MOL switch will be conducted during normal preventive maintenance. AMS expects to complete installation of the switches by end of August 2007.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - USA, Italy, France, Germany, Spain, UK, Denmark, Sweden, Australia, India, Japan, Greece, Switzerland, Saudi Arabia, Thailand, Turkey, Singapore, Taiwan/Hong Kong (China), and Austria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESLaserscope · 2006-12-01K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)Laserscope · 2001-05-01

Official Source

View FDA Recall →

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

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