Product Wiki · Recalls · U.S. FDA — Device Enforcement

Instructions for Use for the following Leksell Stereotactic System… — recall Z-1309-2023

U.S. FDA — Device Enforcement · Sweden · 2023-03-01 · Class II

As described by U.S. FDA — Device Enforcement: 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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1309-2023
Date of alert
2023-03-01
Country / jurisdiction
Sweden
Risk level
Class II
Notice type
recall
Brand
Elekta Instrument AB
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
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.
Barcode (EAN/GTIN)
07340048301305
Reported risk: The incorrect IFU was distributed with the devices.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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