Rappel de produits de santé

StentBoost - Software (2019-03-04)

Starting date:
March 4, 2019
Posting date:
March 22, 2019
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-69380

Affected Products

StentBoost - Software

Reason

In the intended use of the instructions for use the following claim is made: StentBoost assists in stent selection by providing a measurement tool which the operator can use to measure the lesion. However, StentBoost cannot assist in the selection of a stent, because the measurement function is only available after placement of the stent. Please note that the primary use of StentBoost for enhanced stent visualization is not affected. Correct intended use is added to the section "advice on actions by customer/user." This issue does not pose any risk to health of patients, users or bystanders.

Affected products

StentBoost - Software

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1007

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS