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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64601

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 18, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leica Microsystems (Schweiz) Ag

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

Z-2176-2013
Recall number
Z-2176-2013
Initiated
December 18, 2012
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

Code information

Serial Numbers: OH4-84712, OH4-84812, OH4-84912

Distribution pattern

Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.

device · product 2 of 2

Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

Z-2177-2013
Recall number
Z-2177-2013
Initiated
December 18, 2012
Classification
Class II
Status
Terminated
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

Code information

Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312

Distribution pattern

Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.