The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produ

FDA device recall Z-2711-2014 · posted 2014-09-29 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

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

Status

Terminated

Product code

JAK

Quantity affected

79

Distribution

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, Malaysi

Date initiated

2014-09-11

Date posted

2014-09-29

Date terminated

2018-06-26

Location

Cleveland, OH

Related 510(k) clearances