Leksell Stereotactic System Recall: Incorrect Instructions Distributed with Devices
Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. Risk-of-harm product (stereotactic neurosurgery system with incorrect Instructions for Use distributed) with no reported illnesses or injuries, meeting the 'High' severity criterion.
Plain-English summary
Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical instruments due to incorrect Instructions for Use (IFU) being distributed with the devices.
The affected devices were distributed nationwide across 30 US states including Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin, and West Virginia, as well as through government distribution channels.
The recall addresses an issue where incorrect documentation was provided with the stereotactic neurosurgical devices.
The recalled product
- Product
- 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 Evac
- Manufacturer
- Elekta Instrument AB
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
Distributed nationwide across the United States.
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