Recall Z-1221-2010
Leica Microsystems, Inc. · initiated November 12, 2009
Product
Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.
Codes / lots: Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093
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.
FDA-determined cause: Radiation Control for Health and Safety Act
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.
Details
- Recall number
- Z-1221-2010
- Initiated
- November 12, 2009
- Posted by FDA
- May 6, 2010
- Terminated
- May 11, 2010
- Product code
- REM – Spectroscopy Instrument
- Quantity
- 15 microscopes and 8 spare part shutters
- Distribution
- Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.
- Recalling firm
- Leica Microsystems, Inc., Bannockburn, IL