Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Reported: April 25, 2018 Initiated: February 21, 2018 #Z-1396-2018
Product Description
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Reason for Recall
Surview scan with tube current lower than 30 mA is unable to be initialized.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 291
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 291.
Why was this product recalled? ▼
Surview scan with tube current lower than 30 mA is unable to be initialized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1396-2018.
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