Recall Z-1503-2017— Ohmeda Medical
Class II · Terminated
Class II FDA medical device recall by Ohmeda Medical, initiated 2016-11-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K011549. 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. 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..
- Recalling firm
- Ohmeda Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-18
- Terminated
- 2018-07-13
- Firm location
- Laurel, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.