Stereotactic frames recalled because paint flakes may enter the wound
Elekta is recalling 338 Leksell Vantage Stereotactic System components because paint flakes from the engravings may separate and could inadvertently enter the wound.
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: Scored 3 under the risk-of-harm criterion: a paint flake entering a surgical wound is a foreign body hazard, and no injuries are reported.
Plain-English summary
The Leksell Vantage Stereotactic System from Elekta is being recalled. The system is intended for target localisation and fixation of the patient's head during stereotactic procedures.
The recall follows an increased risk that paint flakes from the engravings may separate from the device, with the possibility that a flake may inadvertently enter the wound.
The recall covers 338 units, including the Arc (UDI 07340048304856) and Support Arc (UDI 07340048304849), distributed worldwide including in Arkansas, California, Colorado, Florida, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Montana, North Carolina, Nebraska and New Hampshire. The FDA has classified the action as Class II.
The enforcement record describes the risk and reports no injuries. Sites using an affected system should follow Elekta's instructions.
The recalled product
- Product
- Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in
- Manufacturer
- Elekta, Inc.
- Hazard
- paint-flaking
- foreign-body
- neurosurgery
Distribution
Distributed nationwide across the United States.
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