—#187275

Product

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Serial Numbers: 100100, 100434

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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

Timeline

Recall initiated: 2021-04-13
Terminated: 2022-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187275. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.