Recall Z-2720-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Intuitive Surgical, Inc.
Ion Endoluminal System, REF: 380748-65
| Date | Aug 23, 2024 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways. |
| Root cause | Under Investigation by firm |
| Action | On July 12, 2024, Intuitive issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. An Intuitive Representative will schedule a s |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AZ and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical, Feb 14, 2019 |