Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Ohmeda Medical, A Division of Datex-Ohmeda, Inc. makes
Ohmeda Medical manufactures medical devices for neonatal and pediatric care, including the Giraffe Incubator Carestation CS1—a temperature-controlled incubator—and Giraffe and Panda Warmers, which maintain infant body temperature during treatment.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Giraffe Incubator Carestation CS1 Ref K152809
Regimes: 510(k) Registry: 510(k)Giraffe And Panda Warmers Ref K122267
Regimes: 510(k) Registry: 510(k)Giraffe OmniBed Carestation CS1 Ref K152814
Regimes: 510(k) Registry: 510(k)Giraffe And Panda Warmers Ref K101804
Regimes: CE MDR 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Ohmeda Medical, A Division of Datex-Ohmeda, Inc., the earliest on 2003-06-13 and the most recent on 2005-04-25. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 25 Apr 2005 Z-1047-05 Unclassified (pre-2012) Terminated Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
Full distribution text
- 25 Apr 2005 Z-1047-05 Unclassified (pre-2012) Terminated Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
2003
- 13 Jun 2003 Z-1064-03 Unclassified (pre-2012) Terminated Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
Frequently asked questions
How many devices does Ohmeda Medical, A Division of Datex-Ohmeda, Inc. have in the registry?
The registry currently lists 4 devices for Ohmeda Medical, A Division of Datex-Ohmeda, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ohmeda Medical, A Division of Datex-Ohmeda, Inc.'s devices?
Among its 4 most recently registered devices, Ohmeda Medical, A Division of Datex-Ohmeda, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Ohmeda Medical, A Division of Datex-Ohmeda, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ohmeda Medical, A Division of Datex-Ohmeda, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ohmeda Medical, A Division of Datex-Ohmeda, Inc.?
FDA recall records list 2 recalls initiated by Ohmeda Medical, A Division of Datex-Ohmeda, Inc., the most recent initiated on 25 Apr 2005. 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, A Division of Datex-Ohmeda, Inc. in the registry?
The most recently registered devices listed for Ohmeda Medical, A Division of Datex-Ohmeda, Inc. include Giraffe Incubator Carestation CS1, GIRAFFE AND PANDA WARMERS and Giraffe OmniBed Carestation CS1.