Mckesson Israel, Ltd.
Country not established
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Mckesson Cardiology Hemo Ref K131497
Regimes: 510(k) Registry: 510(k)Horizon Cardiology Ecg Management Ref K113515
Regimes: 510(k) Registry: 510(k)Mckesson Cardiology Ecg Mobile Ref K133534
Regimes: 510(k) Registry: 510(k)Mckesson Horizon Cardiology Ref K112720
Regimes: 510(k) Registry: 510(k)McKesson Cardiology Ref K151850
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 12 Mar 2018 Z-2968-2018 Class II Terminated Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
2014
- 19 Dec 2014 Z-0910-2015 Class II Terminated An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
Frequently asked questions
How many devices does Mckesson Israel, Ltd. have in the registry?
The registry currently lists 5 devices for Mckesson Israel, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mckesson Israel, Ltd.'s devices?
Among its 5 most recently registered devices, Mckesson Israel, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Mckesson Israel, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mckesson Israel, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mckesson Israel, Ltd.?
FDA recall records list 2 recalls initiated by Mckesson Israel, Ltd., the most recent initiated on 12 Mar 2018. 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 Mckesson Israel, Ltd. in the registry?
The most recently registered devices listed for Mckesson Israel, Ltd. include MCKESSON CARDIOLOGY HEMO, HORIZON CARDIOLOGY ECG MANAGEMENT, MCKESSON CARDIOLOGY ECG MOBILE and MCKESSON HORIZON CARDIOLOGY.