Mckesson Information Solutions, LLC
Country not established
- Devices
- 1
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Mckesson Information Solutions, LLC makes
Mckesson Information Solutions, LLC produces the Horizon Perinatal Care Surveillance and Archival software, designed for monitoring and recording fetal and maternal health data during pregnancy and childbirth.
The company’s product is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The software is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Mckesson Information Solutions, LLC, the earliest on 2011-02-02 and the most recent on 2014-08-27. By recorded status: 6 terminated. The reasons filed fall into these groups: software or firmware 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.
2014
- 27 Aug 2014 Z-0042-2015 Class II Terminated Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Full distribution text
- 25 Jun 2014 Z-0093-2015 Class II Terminated McKesson Cardiology Hemo front-end parameter boxes must undergo annual
maintenance testing to establish the proper functioning of the parameter boxes,
and to identify in a timely manner whether a parameter box is out of calibration.
McKesson has identified that its communication to customers regarding the
required maintenance tests was insufficient. While each unit has an attached
sticker i
Full distribution text
- 27 Aug 2014 Z-0042-2015 Class II Terminated Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
2013
- 23 Dec 2013 Z-0976-2014 Class II Terminated Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
- 15 Oct 2013 Z-0556-2014 Class II Terminated When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.
- 4 Sep 2013 Z-2318-2013 Class II Terminated Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Full distribution text
2011
- 2 Feb 2011 Z-3035-2011 Unclassified (pre-2012) Terminated Images for one patient may appear in the study of another patient.
Frequently asked questions
How many devices does Mckesson Information Solutions, LLC have in the registry?
The registry currently lists 1 device for Mckesson Information Solutions, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mckesson Information Solutions, LLC's devices?
Among its 1 most recently registered device, Mckesson Information Solutions, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Mckesson Information Solutions, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Mckesson Information Solutions, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mckesson Information Solutions, LLC?
FDA recall records list 6 recalls initiated by Mckesson Information Solutions, LLC, the most recent initiated on 27 Aug 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 Mckesson Information Solutions, LLC in the registry?
The most recently registered devices listed for Mckesson Information Solutions, LLC include HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0.