Recall Z-0786-2013— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-09-18, terminated 2015-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.. Reason: The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU)..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-18
- Terminated
- 2015-09-02
- Firm location
- Cleveland, OH, United States
Product description
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for recall
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.