Leica Microsystems, Inc.
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
| Date | Jun 25, 2018 |
| Status | Terminated |
| Reason | Recall is due to a design weakness of the power insert module. |
| Root cause | Device Design |
| Action | Leica Microsystems notified customers on about 06/25/2018 via URGENT FIELD SAFETY NOTICE letter. Instructions included advising customers of the issue, informing them that Leica Microsystems representative will contact them to arrange the fiel update to the device, distribute the recall notification to all individuals that should be aware of the recall or if the device was further distributed and a response form was provided to complete and return. The notification letter also instructed customers to report any anomalies with the system to Leica Microsystems if they occur prior to the correc |
| Quantity | 123 devices total |
| Distribution | United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.