Carroll Healthcare, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Carroll Healthcare, Inc. makes
Carroll Healthcare, Inc. manufactures electric hospital beds, including the DLX 2300-111 model, designed for patient care in clinical settings. These beds are adjustable and intended for use in acute care, rehabilitation, and long-term care environments to support patient positioning and mobility.
The company’s products fall under FDA Class II devices and are listed via the 510(k) clearance pathway in the United States. The portfolio is regulated under US medical device laws, with compliance verified through the FDA’s premarket notification process.
Catalogue
Carroll Healthcare Dlx 2300-111 Electric Bed Ref K962250
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Carroll Healthcare, Inc., initiated on 2005-05-17. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 17 May 2005 Z-0919-05 Unclassified (pre-2012) Terminated The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
- 17 May 2005 Z-0920-05 Unclassified (pre-2012) Terminated The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
Frequently asked questions
How many devices does Carroll Healthcare, Inc. have in the registry?
The registry currently lists 1 device for Carroll Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carroll Healthcare, Inc.'s devices?
Among its 1 most recently registered device, Carroll Healthcare, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Carroll Healthcare, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Carroll Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Carroll Healthcare, Inc.?
FDA recall records list 2 recalls initiated by Carroll Healthcare, Inc., the most recent initiated on 17 May 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 Carroll Healthcare, Inc. in the registry?
The most recently registered devices listed for Carroll Healthcare, Inc. include CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED.