Agency classClass IIOur severity:High FDA (Devices)·Z-1309-2023·Announced 2023-04-05

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: Elekta Instrument AB
Category: Medical Device — Neurosurgical instruments
Hazard: mis-labeling
Affected units: 70

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.

The notice also names 30 states specifically:

Same manufacturer · Elekta Instrument AB

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