Olea Sphere V3.0 (2019-04-16)
- Starting date:
- April 16, 2019
- Posting date:
- May 10, 2019
- 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-69872
Last updated: 2019-05-10
Affected Products
Olea Sphere V3.0
Reason
Increase of the use of SMS/multi-band type of acquisition which could potentially lead to errors for the estimation of quantitative parameters.
Affected products
Olea Sphere V3.0
Lot or serial number
Not applicable.
Model or catalog number
OLMV3.0
Companies
- Manufacturer
-
Olea Medical SA
93 Avenue des Sorbiers
La Ciotat
13600
FRANCE