Z-1221-2010

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

Name: Z-1221-2010 Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X...
Creator: Leica Microsystems, Inc.
Published: 2009-11-12
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2009-11-12 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument on 2009-11-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1221-2010
Status: Terminated
Initiated: 2009-11-12
Posted: 2010-05-06
Terminated: 2010-05-11
Recalling firm: Leica Microsystems, Inc.
Product: Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.
Product code: REM Spectroscopy Instrument
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 15 microscopes and 8 spare part shutters
Distribution: Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.
Product codes and lots: Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093

Product code REM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)