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Terminated

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

FDA Recall Z-2111-2016 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-06-21
Date Terminated2018-07-02
Product Quantity3 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033357ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc. · 2004-01-09

Official Source

View FDA Recall →

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

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