Instructions for Use for the following Leksell Stereotactic… recallZ-1309-2023 · Elekta Instrument AB · initiated Mar 1, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Instrument AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The incorrect IFU was distributed with the devices.
FDA root cause category: Labeling Change Control
What the company is doing
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 Acknowledgement Form is enclosed to acknowledge receipt of the notification to Elekta Care Community or complete the form and return it to Elekta no later than within 30 days. The consignee is to provide the device serial number and location or site and sign the form that they had read and understand the notice. On 3/2/2023, the correct IFU version was released to all internal service managers who will ensure all customers received the corrected version.
Recall details
- Recall number
- Z-1309-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 1, 2023
- Posted by the FDA
- Mar 30, 2023
- Recalling firm
- Elekta Instrument AB
- Quantity
- 70 devices
- Product code
- HAW
- FDA submissions
- K152558
- 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.
Product description
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, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
Code information (models, lots, serial numbers)
UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.
Devices named in this recall
12 devices in the FDA device registry whose identifier appears in the recall's code information.
- Leksell Stereotactic System 1002248Elekta Instrument AB · Neurological stereotaxic Instrument1 recall3 reports
- Leksell Stereotactic System Neurosurgical Instruments A2800-15Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 907801Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2200-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2600-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2800-26Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-02Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50376-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50398-01Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 14001050Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 307165Elekta Instrument AB · Neurological stereotaxic Instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K152558 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Leksell Stereotactic System 1002136Elekta Instrument AB · Neurological stereotaxic Instrument3 reports
- Leksell Stereotactic System 1000689Elekta Instrument AB · Neurological stereotaxic Instrument1 death2 reports
- Leksell Stereotactic System Neurosurgical Instruments 911933Elekta Instrument AB · Neurological stereotaxic Instrument1 report
- Leksell Stereotactic System 912877Elekta Instrument AB · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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