Arjo Hospital Equipment AB
Country not established
- Devices
- 1
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Arjo Hospital Equipment AB makes
Arjo Hospital Equipment AB manufactures immersion hydrobaths used in clinical settings.
The company is based in the US, and its devices are classified as Class II medical devices that are listed in the FDA 510(k) registry.
Catalogue
Immersion Hydrobath Ref K082951
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Arjo Hospital Equipment AB, the earliest on 2014-03-17 and the most recent on 2014-12-03. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 3 Dec 2014 Z-1216-2015 Class II Terminated The recalled devices labeling and instructions for use contain unapproved medical claims.
Full distribution text
- 3 Dec 2014 Z-1217-2015 Class II Terminated The recalled devices labeling and instructions for use contain unapproved medical claims.
Full distribution text
- 3 Dec 2014 Z-1218-2015 Class II Terminated The recalled devices labeling and instructions for use contain unapproved medical claims.
Full distribution text
- 1 Sep 2014 Z-1247-2015 Class II Terminated The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
- 17 Mar 2014 Z-0019-2015 Class II Terminated There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.
Full distribution text
- 3 Dec 2014 Z-1216-2015 Class II Terminated The recalled devices labeling and instructions for use contain unapproved medical claims.
Frequently asked questions
How many devices does Arjo Hospital Equipment AB have in the registry?
The registry currently lists 1 device for Arjo Hospital Equipment AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arjo Hospital Equipment AB's devices?
Among its 1 most recently registered device, Arjo Hospital Equipment AB has devices listed in FDA 510(k) (1 device).
What risk classes do Arjo Hospital Equipment AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Arjo Hospital Equipment AB's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arjo Hospital Equipment AB?
FDA recall records list 5 recalls initiated by Arjo Hospital Equipment AB, the most recent initiated on 3 Dec 2014. 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 Arjo Hospital Equipment AB in the registry?
The most recently registered devices listed for Arjo Hospital Equipment AB include IMMERSION HYDROBATH.