—#107302

Product

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional 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 product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.

Why it was recalled

Design defect. Philips learned of this device issue following their receipt of a customer complaint reporting that a 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). A hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Philips, sent an 'URGENT - Medical Device Correction Ingenuity CT***' letter dated December 08, 2011. The letter describes the affected product, the nature of the problem along witth the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. The customers (operator/users) were instructed not to insert hands in the gap which will be located between the gantry and stationary support column located on either side of the CT System (illustrations are provided). The letter notifies the customers that a Philips representative will be visiting each customer site and installing a hardware upgrade through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site 10 or follow prompts).

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.

Timeline

Recall initiated: 2011-12-08
Posted by FDA: 2012-02-16
Terminated: 2013-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.