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Completed

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

FDA Recall Z-0576-2024 · Posted 2023-12-18

Recalling FirmPhilips North America Llc
Recall StatusCompleted
Product CodeJAK
Date Initiated2022-03-29
Product Quantity330 units

Reason for Recall

Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

Firm Action

Customers were sent IMPORTANT PRODUCT NOTICE letters dated 03/29/2022 via USPS. Consignees were asked to identify any affected devices at their facility utilizing the provided instructions, refer to the provided Appendix A for specific details regarding the three issue descriptions and work arounds provided to customers, place the notice with the documentation of the system until all issues have been resolved, and circulate this notice to all users of this device so that they are aware. A Philips Field Service Engineer will contact consignees to schedule a software upgrade. Customers with any questions can contact their local Philips representative and reference FCO72800772 or contact the Customer Care Solutions Center at 1-800-722-9377.

Root Cause

Software design

Distribution Pattern

Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Kosovo, Lao People's Democratic Republic, Latvia, Lebanon, Moldova, Morocco, Netherlands, Palestine, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Saint Pierre and Miquelon, Sint Maarten , South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022-04-27K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018-03-20

Official Source

View FDA Recall →

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

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