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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96220

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 30, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
LEICA BIOSYSTEMS NUSSLOCH GMBH

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

1 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 1

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

Z-1247-2025
Recall number
Z-1247-2025
Initiated
January 30, 2025
Classification
Class II
Status
Ongoing
Quantity
2

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues related to most recent firmware update which could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

Code information

Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

Distribution pattern

Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.

Field note

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