Mckesson Information Solutions, LLC
Philedelphia, PA, US
Mckesson Information Solutions, LLC appears in FDA device records in Philedelphia, PA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Mckesson Information Solutions, LLC in 2011.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0042-2015 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. | Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. | Class II | Terminated | |
| Z-0093-2015 | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. | 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 | Class II | Terminated | |
| Z-0976-2014 | Horizon Medical Imaging, Picture Archive Communication System (PACS). | 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. | Class II | Terminated | |
| Z-0556-2014 | McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). | 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. | Class II | Terminated | |
| Z-2318-2013 | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems. | Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss. | Class II | Terminated | |
| Z-3035-2011 | Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | Images for one patient may appear in the study of another patient. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain