Recall Z-1648-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
| Date | May 22, 2015 (initiated Mar 16, 2015) |
| Status | Terminated |
| Reason | The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. |
| Root cause | Employee error |
| Action | On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers. |
| Quantity | 153 units total |
| Distribution | Distributed in China. |
| 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 |