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Terminated

Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.

FDA Recall Z-2659-2018 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Date Initiated2018-06-25
Date Terminated2019-02-26
Product Quantity123 devices total

Reason for Recall

Recall is due to a design weakness of the power insert module.

Firm 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 correction being made and to ensure a functional check is performed prior to each surgery as described in the user manual.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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