The Recall Desk
HighFDA (Devices)·Z-2076-2019·Announced 2019-07-31

Laborie Medical Technologies Recalls U3-3 Solar Blue Power Supply Units

Laborie Medical Technologies is recalling two U3-3 Solar Blue power supply units due to incorrect labeling and insulation material that does not meet flammability requirements, posing a potential fire hazard.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (fire hazard) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.

Plain-English summary

Laborie Medical Technologies, Corp is recalling two units of the U3-3 Solar Blue laptop integrated power supply. This device is used with the Solar Blue Urodynamics system for assessing lower urinary tract dysfunctions. The specific units affected have serial numbers PE18-7SBL1452 and PE18-7SBL 1414.

The recall was initiated because the power supply unit (PS-SBL) is not correctly labeled. Additionally, the insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. These defects may lead to a potential fire hazard.

The affected units were distributed in the United States, specifically in Arizona and Pennsylvania. Users of these specific serial numbers should contact Laborie Medical Technologies for instructions on how to resolve the issue.

The recalled product

Product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Manufacturer
LABORIE MEDICAL TECHNOLOGIES, CORP
Category
Medical Device — Power Supply
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 2 states:

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