Recall Z-0693-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different
| Date | Jan 11, 2012 (initiated Nov 11, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |