—#150772

Product

Philips Healthcare System X-ray Tomography Computed :

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, Brilliance Big Bore.

Why it was recalled

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.

Timeline

Recall initiated: 2016-03-15
Terminated: 2020-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.