Recall Z-1899-2010 ยท DQK Computer, Diagnostic, Programmable
McKesson Provider Technologies - Medical Imaging Group
Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
| Date | Jun 24, 2010 (initiated Jan 27, 2010) |
| Status | Terminated |
| Reason | McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record. |
| Root cause | Software design |
| Action | The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>M |
| Quantity | 22 devices |
| Distribution | Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050561 | WINDSURFER Medcon , Ltd., May 4, 2005 |