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Q-Station (2015-05-21)
- Starting date:
- May 21, 2015
- Posting date:
- June 10, 2015
- 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-53731
Recalled Products
A. Q-Station
Reason
Philips Healthcare has discovered a problem in the Philips Ultrasound Q-station software version 3.0 or higher that could result in measurements from a study to be appended to subsequent studies for other patients. If a healthcare provider makes a clinical decision on the sole basis of these measurements, without considering other available clinical data, misdiagnosis and/or delayed or incorrect therapy may result.
Affected products
A. Q-Station
Lot or serial number
All lots.
Model or catalog number
Q-STATION
Companies
- Manufacturer
-
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES