Philips North America Llc Recall 87872
Description: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Philips North America Llc Recall 87872 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1774-2021 |
Event ID | 87872 |
Event Description | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan. |
Quantity | 2 units (1 US and 1 OUS) |
Recall Reason | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury |
Device Classification | 20210609 |
Device Code Info | Serial Numbers: 100100, 100434 |
Center Classification Date | 20210602 |
Recall Initiation Date | 20210413 |
Recalling Firm | Philips North America Llc |
Initial Notification | Telephone |
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