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Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless-Steel Debris on the Inside of the Biopsy Needle 

Elekta Instrument AB is recalling Disposable Biopsy Needles (911933) from one batch (837838839) which can contain some microscopic stainless-steel debris on the inside of the biopsy needle. The presence of debris in biopsy samples can hinder examination and delay the process. Moreover, there's a risk of debris being deposited in the brain, which could affect future MRI scans, potentially rendering them useless or unobtainable.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

If you have questions about this recall, contact Elekta Instrument AB at (855) 693-5358.