Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 3000

FDA device recall Z-0693-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Component defect. When the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction.

Action taken

Philips sent an 'URGENT - Medical Device Correction Ingenuity CT' letter dated November 15, 2011. The letter describes the affected product, problem, hazard involved and actions to be taken by the customer and user. In this case, the customers are advised that extra care should be taken when using the 8-way Gantry Panel switch so as to avoid inadvertently activating an unintended switch resulting in unwanted (couch) movement. The letter notifies the customers that a Philips representative will be visiting each customer site and installing a new control panel 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 ID or follow prompts).

Root cause

Device Design

Status

Terminated

Product code

JAK

Quantity affected

13 system units were distributed (5 in U.S. & 8 overseas)

Distribution

Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.

Date initiated

2011-11-11

Date posted

2012-01-11

Date terminated

2013-02-22

Location

Cleveland, OH

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