—#101478

Product

Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010817
Affected lot / code info: The following Serial Numbers of the CT X-ray Scanners are subject to recall/correction: 8008-8413, 80001-800022.

Why it was recalled

Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical

Root cause (FDA determination)

Device Design

Action the firm took

Philips Medical Systems (Cleveland) Inc. issued an "URGENT - Medical Device Correction - Field Safety Notice" letter dated June 1, 2011 to all affected customers, via Certified Mail for tracking purposes. The notification identified the product, the problem involved, and the action(s) to be taken by the customers with regard to this device issue. The notification instructs the customers to monitor their units and if the recalled product malfunctions, to immediately notify their Phillips service representative. The letter also states that a Philips Field Service Engineer will visit each customer location and perform a brake repair or replacement on their system to resolve the issue. For further information or support, the customers are instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada the customers are instructed to contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompt(s).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) including the states of: AR, AZ, CA, CO, FL, FA, HI, IL, IN, KY, MA, MI, MO, MS, NC, NV, NY, OH, OK, SC, SD, TN, TX, VA, VT, WA and Puerto Rico and the country of Canada.

Timeline

Recall initiated: 2011-06-03
Posted by FDA: 2011-08-01
Terminated: 2013-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.