Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A280

FDA device recall Z-1309-2023 · posted 2023-03-30 · Open, Classified

Recall details

Recalling firm

Elekta Instrument AB

Reason for recall

The incorrect IFU was distributed with the devices.

Action taken

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.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

HAW

Quantity affected

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 distri

Date initiated

2023-03-01

Date posted

2023-03-30

Location

Stockholm, Sweden

Related 510(k) clearances