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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83310

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

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Event summary

Timeline bucket
July 17, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LABORIE MEDICAL TECHNOLOGIES, CORP

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

U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions

Z-2076-2019
Recall number
Z-2076-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Quantity
2 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard

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

Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard

Code information

Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414

Distribution pattern

US distribution in AZ, and PA.