—#147803

Product

Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: 921216

Why it was recalled

Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Timeline

Recall initiated: 2016-06-21
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147803. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.