FDA Recall
Terminated
Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Recall: Z-0710-2008
·
Initiated November 12, 2007
Recall
- Recall Number
- Z-0710-2008
- Event Number
- 46276
- Firm
- McKesson Provider Technologies
- FEI Number
- 3005157178
- Product Code
- DQK
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 12, 2007
- Posted
- February 5, 2008
- Terminated
- May 28, 2008
- Address
- 628 State Route 10, Whippany, NJ, 07981-1522
Description
Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Reason
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
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.
Distribution
Nationwide to hospital and medical centers in LA. CA, PA and IL,
Quantity
13