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Haloflex Energy Generator
- Starting date:
- September 24, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Product Safety
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15876
Recalled Products
1. Haloflex Energy Generator
Reason
There is a generator malfunction where Haloflex Energy Generator failed to enter "Standby mode" when initially powered-on (plugged in and turned on). During normal use when the device is powered-on, the generator automatically sequences through a "Power-on self test" to check for proper function. If the generator passes the self- test, it enters standby mode, displays "Ready, connect catheter" and is ready for use. Patient injury has not been seen with this malfunction.
Affected products
1. Haloflex Energy Generator
Lot or serial number
010410-001, 010410-002, 090909-009, 100711-003, 100711-004, 100711-005, 111209-009, FE103845.20
Model or catalog number
1190A-115A
1190A-230A
Companies
- Manufacturer
- Barrx Medical Inc.