Recall Z-1510-2017 ยท FMZ Incubator, Neonatal
Ohmeda Medical
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators provide a controlled thermal environment for neonates who are unable to provide th
| Date | Nov 18, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal |
| Quantity | 5,993 (5,080 US; 913 OUS) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974349 | OHMEDA-OHIO CARE PLUS INCUBATOR Ohmeda Medical, Feb 12, 1998 |