Ohmeda Medical
Country not established
- Devices
- 120
- FDA recalls
- 13
At a glance
Market reach
- United States
- FDA recalls
What Ohmeda Medical makes
The company manufactures neonatal and pediatric warming devices, including uninterruptible power supply systems for incubators and warmers, as well as neonatal incubators and high-output phototherapy systems for treating jaundice. It also produces anesthesia ventilators, syringe pumps for precise medication delivery, and a Bain circuit adapter for respiratory support. Additional products include an intensive care ventilator and an insufflation device for surgical procedures.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These devices are intended for use in critical care, anesthesia, and neonatal settings. The company is based in the United States.
Catalogue
Search and filter all 120 devicesShowing 1-50 of 120
FDA recalls
FDA recall records list 13 recalls initiated by Ohmeda Medical, the earliest on 2016-11-18 and the most recent on 2018-10-05. By recorded status: 13 terminated. The reasons filed fall into these groups: packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 5 Oct 2018 Z-0041-2020 Class II Terminated GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
2017
- 1 Dec 2017 Z-1181-2018 Class II Terminated There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
2016
- 18 Nov 2016 Z-1501-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1502-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1503-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1504-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1505-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1506-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1507-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1508-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1501-2017 Class II Terminated 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.
Show all 13 recalls
2016
- 18 Nov 2016 Z-1509-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1510-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1511-2017 Class II Terminated 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.
Full distribution text
- 18 Nov 2016 Z-1509-2017 Class II Terminated 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.
Frequently asked questions
How many devices does Ohmeda Medical have in the registry?
The registry currently lists 120 devices for Ohmeda Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ohmeda Medical's devices?
Among its 50 most recently registered devices, Ohmeda Medical has devices listed in FDA 510(k) (50 devices).
What risk classes do Ohmeda Medical's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ohmeda Medical's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ohmeda Medical?
FDA recall records list 13 recalls initiated by Ohmeda Medical, the most recent initiated on 2018-10-05. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ohmeda Medical in the registry?
The most recently registered devices listed for Ohmeda Medical include MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY), OHMEDA MEDICAL OMNIBED, OHMEDA 7900 ANESTHESIA VENTILATOR and BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM.