Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and

FDA device recall Z-1046-2012 · posted 2012-02-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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

Action taken

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).

Root cause

Device Design

Status

Terminated

Product code

JAK

Quantity affected

Four (4) device system units were distributed. Two (2) in U.S. and two (2) overseas

Distribution

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

Date initiated

2011-12-08

Date posted

2012-02-16

Date terminated

2013-03-01

Location

Cleveland, OH

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