I.T.S. GmbH - 212141-7, 212141-8, 212151-7, 212151-8, 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7, 21208-13, 21209-13, 21208-11, 21209-11, 212061-10, 212061-14, 212071-10, 212071-14, 211751-5, 211771-4, 211821-10, 211821-11, 211821-12, 211821-14, 21161-4, 21161-6, 211621-4, 211621-6, 211631-6, 211631-8
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. GmbH - 212141-7, 212141-8, 212151-7, 212151-8, 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7, 21208-13, 21209-13, 21208-11, 21209-11, 212061-10, 212061-14, 212071-10, 212071-14, 211751-5, 211771-4, 211821-10, 211821-11, 211821-12, 211821-14, 21161-4, 21161-6, 211621-4, 211621-6, 211631-6, 211631-8
No specific danger identified
All
Check for proper labeling and compliance with safety standards
No specific danger identified
I.T.S. GmbH products including 212141-7, 212141-8, 212151-7, 212151-8, 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7, 21208-13, 21209-13, 21208-11, 21209-11, 212061-10, 212061-14, 212071-10, 212071-14, 211751-5, 211771-4, 211821-10, 211821-11, 211821-12, 211821-14, 21161-4, 21161-6, 211621-4, 211621-6, 211631-6, 211631-8
We’ve drafted a message you can send I.T.S. GmbH to request your refund or repair — edit it as you like.
Subject: Recall Z-1608-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1608-2026 from I.T.S. GmbH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.