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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84415

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

Open FDA event record

Event summary

Timeline bucket
November 05, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
King Systems Corp. dba Ambu, 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

King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12

Z-0916-2020
Recall number
Z-0916-2020
Initiated
November 05, 2019
Classification
Class I
Status
Terminated
Quantity
171 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.

Code information

Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666

Distribution pattern

Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.