Recall Z-2600-2025 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
| Date | Sep 19, 2025 (initiated Aug 13, 2025) |
| Status | Open, Classified |
| Reason | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Root cause | Process control |
| Action | Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter |
| Quantity | 285 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauriti |
| 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 |