Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon
FDA device recall Z-0710-2008 · posted 2008-02-05 · Terminated
Recall details
- Recalling firm
- McKesson Provider Technologies
- Reason for recall
- Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
- Action taken
- Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 13
- Distribution
- Nationwide to hospital and medical centers in LA. CA, PA and IL,
- Date initiated
- 2007-11-12
- Date posted
- 2008-02-05
- Date terminated
- 2008-05-28
- Location
- Whippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WINDSURFER (K050561) | Medcon , Ltd. | 2005-05-04 |