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Terminated

The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories

FDA Recall Z-2711-2014 · Posted 2014-09-29

Recall StatusTerminated
Product CodeJAK
Date Initiated2014-09-11
Date Terminated2018-06-26
Product Quantity79

Reason for Recall

Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.

Firm Action

Philips sent an Urgent - Field Safety Notice Medical Device Correction letter dated September 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center (1.800.722-9377 and follow the prompts).

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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