BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reported: June 9, 2021 Initiated: April 13, 2021 #Z-1774-2021
Product Description
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reason for Recall
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 2 units (1 US and 1 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306. Recalled by Philips North America Llc. Units affected: 2 units (1 US and 1 OUS).
Why was this product recalled? ▼
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1774-2021.
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