Recall Z-0106-2022 ยท EOQ Bronchoscope (Flexible Or Rigid)
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
| Date | Aug 6, 2021 |
| Status | Terminated |
| Reason | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. |
| Root cause | Under Investigation by firm |
| Action | On August 6, 2021, Intuitive Surgical issued an "Urgent Medical Device Recall" notice to affected consignees via Fed Ex. In addition to informing consignees about the recall, Intuitive ask consignees to take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform affected personnel when the requested actions have been completed. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. 5. All returned a |
| Quantity | 1625 units |
| Distribution | US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China |
| 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 |