FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of McKessonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list McKesson Information Solutions with 5 device recalls and 1 510(k) clearance. The most recent is a device recall dated Aug 27, 2014: McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, cl….
| Aug 27, 2014 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data procClass II · Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is | Device recalls |
| Jun 25, 2014 | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisitClass II · McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper func | Device recalls |
| Dec 23, 2013 | Horizon Medical Imaging, Picture Archive Communication System (PACS).Class II · Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being disp | Device recalls |
| Oct 15, 2013 | McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).Class II · When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is | Device recalls |
| Sep 4, 2013 | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and informClass II · Software malfunction may occur resulting in a certain combination of server configurations which has the potential to ca | Device recalls |
| May 5, 2011 | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0K102263 · HGM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
