Recall Z-1309-2023 ยท HAW Neurological Stereotaxic Instrument
Elekta Instrument AB
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Cathe
| Date | Mar 30, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | The incorrect IFU was distributed with the devices. |
| Root cause | Labeling Change Control |
| Action | The firm issued a Field Safety Notification dated February 2023 on 3/1/2023 via email. The notification describes the problem, lists the part numbers involved, the clinical impact, and recommended user actions also letting them know the correct IFU will be shipped to all affected customers. The recommended user actions include posting the notice in a place accessible to all users until this action is closed and advising the appropriate personnel working with the product on the content of the letter. The consignee is informed that Elekta will provide customers with the correct IFU. An Ackno |
| Quantity | 70 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit Elekta Instrument AB, Mar 2, 2016 |