Recall Z-1273-2021 ยท JAK System, X-Ray, Tomography, Computed
Philips Healthcare (Suzhou) Co., Ltd.
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
| Date | Feb 24, 2021 |
| Status | Terminated |
| Reason | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position. |
| Root cause | Process control |
| Action | On 2/18/2021, Philips issued an Urgent Medical Device Correction because the firm has detected an issue with some actuators used in the couch of Incisive CT and Access CT systems, which could result in the couch unexpectedly moving slowly downward to its limit position. |
| Quantity | 109 systems |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekist |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180015 | Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd., Mar 20, 2018 |