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Actiwatch Spectrum Plus (2014-06-02)
- Starting date:
- June 2, 2014
- Posting date:
- January 21, 2015
- 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-43393
Actiwatch Spectrum Plus
Reason
The distributed Actiwatch Spectrum Plus devices were originally classified by Respironics as a Class I rule 12 medical devices using the classifications rules for medical devices found in schedule 1 of the Medical Device Regulations. As indicated by Health Canada, the device was deemed to be a Class II device requiring a license prior to product distribution.
Affected products
Actiwatch Spectrum Plus
Lot or serial number
Not applicable.
Model or catalog number
1101894
Companies
- Manufacturer
-
Respironics Inc.
1001 Murry Ridge Lane
Murrysville
15668
Pennsylvania
UNITED STATES