Recall Z-0946-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes.
| Date | Feb 3, 2012 (initiated Dec 13, 2011) |
| Status | Terminated |
| Reason | The Block and Multi Leaf Collimator (MLC) shape is not propagated to the beam that is modified by the Oppose operation. The contours can appear with the incorrect color in the Beam's Eye View Viewer, resulting in organs being incorrectly placed or incorrectly shaped. |
| Root cause | Software design |
| Action | On 12/13/2011, the firm sent Field Safety Notices, entitled URGENT - Medical Device Correction, to their customers. The letter identified the affected product, the problem, the hazard involved, and the actions to be taken by customers and the firm. Customers were to follow the instructions provided in order to address or avoid the issues. Philips will be installing a software update to address the identified issues free of charge. If customers need further information or support in regards to these issues, they are to contact their local Philips representative or local Philips Healthcare o |
| Quantity | 142 Units |
| Distribution | Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NM, NY, OH, OR, PA, PR, TN, TX, VA, & WA and countries of AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, DOMINICAN REPUBLIC, FRANCE, GABON, GERMANY, HUNGARY, ISRAEL, ITALY, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |