FDA Device recall Z-1510-2017
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provi…
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provi… by Ohmeda Medical, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-18 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ohmeda Medical |
| Distribution | US |
Product
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 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 can be used in two operating modes: 1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician s training and experience and then is adjusted based on the patient s needs and clinical status. 2. Patient control: The clinician sets the desired patient temperature. A skin temperature probe sense the patient temperature and feeds this information to the controller of the incubator. Thecontroller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Incubators have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems
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.
Identifiers
| code_info | See Attached Spreadsheat |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.