Leica Microsystems, Inc. Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.
Brand
Leica Microsystems, Inc.
Lot Codes / Batch Numbers
Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093
Products Sold
Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093
Leica Microsystems, Inc. is recalling Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS S due to A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026