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Recall Observatory FDA recall evidence

Device product

Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital

Z-1503-2017

November 18, 2016

Class II

Product summary

Firm
Ohmeda Medical
Event
Event 76283
Status
Terminated
Classification
Class II
Quantity
5,993 (5,080 US; 913 OUS)
Official record key
device-enforcement:Z-1503-2017

Official wording

Reason: Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

Code information: See Attached Spreadsheat

Distribution pattern: Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.