Recall Z-0391-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Nov 10, 2017 |
| Status | Terminated |
| Reason | Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm. |
| Root cause | Under Investigation by firm |
| Action | An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips |
| Quantity | 3 |
| Distribution | Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc., Aug 8, 2016 |