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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
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