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

FDA device recall Z-1221-2010 · posted 2010-05-06 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

Action taken

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 clsm.qc@leica-microsystems.com. 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

Status

Terminated

Product code

REM

Quantity affected

15 microscopes and 8 spare part shutters

Distribution

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

Date initiated

2009-11-12

Date posted

2010-05-06

Date terminated

2010-05-11

Location

Bannockburn, IL