Edwards Systems (2016-05-26)

Starting date:

May 26, 2016

Posting date:

June 13, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58848

• Reason
• Affected products

Affected products

1. EDWARDS EV1000 SYSTEM - MONITOR
2. EDWARDS EV1000 SYSTEM - DATA BOX
3. EDWARDS EV1000 SYSTEM - ETHERNET CABLE
4. EDWARDS EV1000 SYSTEM - BIFURCATED POWER SUPPLY
5. EDWARDS EV1000 SYSTEM - POWER ADAPTER
6. EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODIULTION CABLE
7. EDWARDS EV1000 SYSTEM - FLOTRAC CABLE

Reason

Edwards Lifesciences has initiated a voluntary safety alert regarding the EV1000A system to reinforce the proper set up of the external power supply according to the equipment's operator manual.

The company received a recent event of an electrical fire, therefore is sending a notice to all customers with EV1000A systems installed to confirm installation against the current requirements documented in the operator's manual section EV1000 power adapter mounting bracket.

Affected products