Intel-GE Care Innovations, LLC
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Intel-GE Care Innovations, LLC makes
Intel-Ge Care Innovations produces medical devices for patient monitoring and imaging support, including the QuietCare system for noise reduction in healthcare environments, the Connect RCM for remote cardiac monitoring, and modifications to the Guide system for procedural imaging assistance.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Intel-Ge Care Innovations Quietcare Ref K131585
Regimes: 510(k) Registry: 510(k)Intel-Ge Care Innovations Connect Rcm Ref K130821
Regimes: 510(k) Registry: 510(k)Modification To Intel-Ge Care Iinovations Guide Ref K130290
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Intel-Ge Care Innovations, LLC, the earliest on 2011-07-30 and the most recent on 2017-12-06. By recorded status: 6 terminated. The reasons filed fall into these groups: software or firmware 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 6 Dec 2017 Z-2442-2018 Class II Terminated It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.
2013
- 4 Apr 2013 Z-1374-2013 Class II Terminated Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
- 4 Apr 2013 Z-1375-2013 Class II Terminated Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
2012
- 16 Dec 2012 Z-0877-2013 Class II Terminated Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered.
2011
- 1 Aug 2011 Z-1703-2012 Unclassified (pre-2012) Terminated On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a
Full distribution text
- 30 Jul 2011 Z-1615-2012 Unclassified (pre-2012) Terminated The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a fe
- 1 Aug 2011 Z-1703-2012 Unclassified (pre-2012) Terminated On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a
Frequently asked questions
How many devices does Intel-Ge Care Innovations, LLC have in the registry?
The registry currently lists 3 devices for Intel-Ge Care Innovations, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intel-Ge Care Innovations, LLC's devices?
Among its 3 most recently registered devices, Intel-Ge Care Innovations, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Intel-Ge Care Innovations, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Intel-Ge Care Innovations, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intel-Ge Care Innovations, LLC?
FDA recall records list 6 recalls initiated by Intel-Ge Care Innovations, LLC, the most recent initiated on 6 Dec 2017. 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 Intel-Ge Care Innovations, LLC in the registry?
The most recently registered devices listed for Intel-Ge Care Innovations, LLC include INTEL-GE CARE INNOVATIONS QUIETCARE, INTEL-GE CARE INNOVATIONS CONNECT RCM and MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE.