Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reported: January 31, 2018 Initiated: July 11, 2017 #Z-0403-2018
Product Description
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reason for Recall
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 559 total
- Distribution
- Worldwide distribution, including US nationwide.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Brilliance iCT - Model 728306 Computed Tomography X-ray systems. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 559 total.
Why was this product recalled? ▼
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0403-2018.
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