—#147530

Product

Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023

Why it was recalled

Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Philips Medical Systems (Cleveland) Inc. sent an Urgent Field Safety Notice letter to affected customers , via certified letter with receipts returned for tracking purposes. The letter identified the affected product, problem and actions to be taken. Philips Healthcare is implementing software update version 3.5.5 to correct the problem. For questions contact your local Philips representative or local Philips Healthcare office.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX

Timeline

Recall initiated: 2016-04-01
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.