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Terminated

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

FDA Recall Z-1774-2021 · Posted None

Recalling FirmPhilips North America Llc
Recall StatusTerminated
Product CodeJAK
Date Initiated2021-04-13
Date Terminated2022-09-23
Product Quantity2 units (1 US and 1 OUS)

Reason for Recall

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

Firm Action

Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060937BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc. · 2006-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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