Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Reported: December 16, 2015 Initiated: April 25, 2006 #Z-0400-2016
Product Description
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Reason for Recall
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 54 units
- Distribution
- Worldwide distribution, including US states of CA and NV.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 54 units.
Why was this product recalled? ▼
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0400-2016.
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