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Digital Inclinometer (2014-09-24)
- Starting date:
- September 24, 2014
- Posting date:
- October 2, 2014
- 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-41627
Recalled Products
Digital Inclinometer
Reason
It was found during a routine audit by Health Canada on Sept.3rd, 2014, that the devices were misclassified as Class I. Devices should be classified as Class II, but do not have Class II device licence.
Affected products
Digital Inclinometer
Lot or serial number
ACU360
DC360
Model or catalog number
ACU001
ACU002
Companies
- Manufacturer
-
Lafayette Instrument Company,
3700 Sagamore Parkway North,
Lafayette
47903
Indiana
UNITED STATES