Recall Z-1221-2010 ยท REM Spectroscopy Instrument
Leica Microsystems, Inc.
Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.
| Date | May 6, 2010 (initiated Nov 12, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| 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 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. |
| Quantity | 15 microscopes and 8 spare part shutters |
| Distribution | Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.