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Matrx Plus
- Starting date:
- July 18, 2017
- Posting date:
- August 15, 2017
- 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-64234
Reason
Internal quality control found that the Matrx Plus may incorrectly position the mandible during a test up to 2mm. The device's functional check may also allow the device to be used with a positional inaccuracy of up to 0.5mm.
Affected products
Matrx Plus
Lot or serial number
MP S/N/: C170020
MP S/N: C170003 to C170013
MP S/N: C170017 to C170018
Tablet S/N: E170003 to E170013
Tablet S/N: E170015
Tablet S/N: E170016
Model or catalog number
CAT-001-01
Companies
- Manufacturer
-
ZEPHYR SLEEP TECHNOLOGIES
610 UNIT A, 70TH AVE SE
Calgary
T2H 2J6
Alberta
CANADA