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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92945

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

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Event summary

Timeline bucket
September 16, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Icecure Medical Ltd

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

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

Z-2650-2023
Recall number
Z-2650-2023
Initiated
September 16, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Icecure Medical Ltd
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

Code information

UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.

Distribution pattern

US Nationwide distribution.