Exact FDA event identifier

Event 79884

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

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Event summary

Timeline bucket: April 11, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ninepoint Medical Inc.

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

NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

Z-1781-2018

Recall number: Z-1781-2018
Initiated: April 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ninepoint Medical Inc.
Quantity: 152

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Distal tips of the probes may detach from the probe shaft during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Distal tips of the probes may detach from the probe shaft during use.

Code information

Lot Numbers: 005196, 005251, 005275

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX