Recall Z-1923-2020 ยท JAK System, X-Ray, Tomography, Computed
Philips North America, LLC
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
| Date | May 6, 2020 (initiated Apr 6, 2020) |
| Status | Terminated |
| Reason | The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. |
| Root cause | Process control |
| Action | Philips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing |
| Quantity | 2 |
| Distribution | Worldwide distribution including one unit distributed to Iowa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193454 | IQon Spectral CT Philips Medical Systems Nederland B.V., Jan 24, 2020 |