The Recall Desk
SevereFDA (Devices)·Z-1503-2017·Announced 2017-03-29

Ohmeda Medical Spot PT Lite Phototherapy System Recalled for Power Cord Fire Risk

Ohmeda Medical is recalling Spot PT Lite Phototherapy Systems because certain power cords could overheat, posing a risk of fire or thermal injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and thermal injury, which meets the criteria for a Severe rating (score 4) due to the potential for significant injury or property damage.

Plain-English summary

Ohmeda Medical is recalling the Giraffe Spot PT and Spot PT Lite Phototherapy Systems. These devices provide light therapy for the treatment of hyperbilirubinemia (neonatal jaundice) in newborns during the hospital period. The recall involves 5,993 units, with 5,080 distributed in the US (including Puerto Rico) and 913 distributed internationally.

The recall is due to a defect in certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords. These power cords could overheat where they connect to the wall outlet. This overheating could result in fire, charring, smoke, or sparking, which could cause thermal injury.

The affected units were distributed nationwide in the US and Puerto Rico, as well as internationally to the Bahamas, UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela. Users should stop using the affected power cords immediately and contact Ohmeda Medical for instructions on replacement or repair.

The recalled product

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
Manufacturer
Ohmeda Medical
Category
Medical Device — Phototherapy
Hazard

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 (1)

  • See Attached Spreadsheat

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Ohmeda Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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Same hazard · fire

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