Reported Sep 9, 2015 · Terminated

Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model…

Physician Engineered Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Physician Engineered Products, Inc. · 103 Smith St · Fryeburg, ME · 04037-1182

Is this the product you have?

  • Bright Embrace, a Single Bili Light
  • for newborn phototherapy Distributed byPhysician Engineered Products, Inc., Model SBL60
Lot codes and dates
  • Serial Numbers
    • 1002565
    • 1002579
    • 1002632
    • 1002644
    • 1002655
    • 1002688
    • 1002689
    • 1002736
    • 1002746
    • 1002753-1002762
    (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)
Amount recalled
97 units

Where it was sold

Why it was recalled

Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 2, 2015 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.