Recall Z-1756-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
The Oncology Essentials Package of the Spectral CT imaging system.
| Date | May 2, 2024 (initiated Mar 29, 2024) |
| Status | Open, Classified |
| Reason | Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction Letter, dated 3/27/24, was mailed to consignees to notify them of this recall. Consignees are instructed to identify if a third-party laser was installed on their system and if the laser line is reflected, duplicated, or thickened. If a third-party laser is installed, before treatment of a patient, reposition or re-image as necessary to verify proper placement of the localization laser marks. Systems may continue to be used in accordance with the intended use and provided use recommendations. Consignees are to complete and return the provided response form b |
| Quantity | 12 units |
| Distribution | Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203020 | Spectral CT Philips Medical Systems Nederland B.V., Feb 26, 2021 |