PlainRecalls
FDA Devices Moderate Class II 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.

Reported: December 27, 2023 Initiated: March 29, 2022 #Z-0576-2024

Product Description

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.

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
330 units
Distribution
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.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Philips North America Llc. Units affected: 330 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0576-2024.