FDA Medical Device Recalls (openFDA)
McKesson Provider Technologies: 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 number
- Z-0710-2008
- Recalling firm
- McKesson Provider Technologies
- Product
- 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.
- Status
- Terminated
- Initiated
- 2007-11-12
- Posted
- 2008-02-05
- Terminated
- 2008-05-28
- 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.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 13
- Distribution
- Nationwide to hospital and medical centers in LA. CA, PA and IL,
- Lot, serial or model codes
- Serial Numbers of subassemblies (ECUs) that contain the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210, A0225, A0232, A0233, A0234, A0235, and A0236
- 510(k) numbers
- ["K050561"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3005157178
- Firm city
- Whippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28