Recall Z-1693-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles
| Date | May 30, 2012 (initiated Mar 26, 2012) |
| Status | Terminated |
| Reason | Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack. |
| Root cause | Nonconforming Material/Component |
| Action | Philips issued an 'URGENT Medical Device Correction' letter dated March 27, 2012 to all affected customers. The letter identified the affected products, problem, hazard involved, how to identify affected products, and actions to be taken by customer/user. The letter informed customers that Philips intends to dispatching service personnel to each customer site in order to correct this issue. In the meantime, the letter recommend customer to contact their Philips representative if they hear unusual noises when moving the couch vertically, or if there is unintended vertical motion of the couch. |
| Quantity | 3 units were distributed in the U.S. |
| Distribution | Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |