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Terminated

Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.

FDA Recall Z-1221-2010 · Posted 2010-05-06

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeREM
Date Initiated2009-11-12
Date Terminated2010-05-11
Product Quantity15 microscopes and 8 spare part shutters

Reason for Recall

A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.

Firm Action

A Service Note was sent to service organizations on November 12, 2009. The communication asked customers to check if they must exchange their shutters and send their planned exchange date by 2009-11-20 to [email protected]. Customers were also asked to check the serial numbers of the one-wire chips of the shutters. Then lastly, the were asked to exchange the shutters and confirm the exchange.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.

Official Source

View FDA Recall →

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

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