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H3+ (PLUS) HOLTER RECORDER (2015-11-03)
- Starting date:
- November 3, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56084
Affected Products
H3+ (PLUS) HOLTER RECORDER
Reason
An issue with the placement of a capacitor in the H3+ Digital Holter 48 hour recorders has resulted in reduced battery life, causing the recorder to record for less than the expected time. H3+ Digital Holter recorders with serial numbers between 115110248400 and 115410276012 fail to meet the claim of 24-48 hours recording time.
Affected products
H3+ (PLUS) HOLTER RECORDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- BURH3PR
- H3PLUS-BAD-XXXXX
Companies
- Manufacturer
-
Mortara Instrument Inc.,
7865 North 86th St.,
Milwaukee
53224
Wisconsin
UNITED STATES