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Bio-Console®
MEDTRONIC, INC. · Model R560BCS1 · UDI-DI 00763000236540
DWA
Prescription
1
510(k) clearances
3,469
Adverse events (48 deaths)
12
Recalls
21
Facilities
Description
REFURB CONSOL R560BCS1 W/S BRD 7L NR EMC
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-05 | Cardiac Assist, Inc | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the |
| 2022-07-21 | Cardiac Assist, Inc | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. |
| 2021-12-17 | LivaNova Deutschland GmbH | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| 2021-03-03 | Medtronic Perfusion Systems | An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed i |
| 2019-08-26 | LivaNova Deutschland GmbH | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible |
| 2019-08-26 | LivaNova Deutschland GmbH | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible |
| 2017-10-30 | Sorin Group Deutschland GmbH | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 |
| 2013-12-04 | Sorin Group Deutschland GmbH | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. |
| 2012-09-20 | Sorin Group USA, Inc. | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification |
| 2012-09-20 | Sorin Group USA, Inc. | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.