I.T.S. recalls DUL and UOL surgical systems due to potential MRI heating risks. Updated MRI safety testing shows higher RF temperature increases than previously stated in instructions.
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. is recalling two surgical systems (DUL and UOL) because MRI safety testing shows they could heat up more than previously reported during certain MRI scans. This could cause burns or other injuries if used with MRI machines.
The surgical systems can cause higher temperature increases during MRI scans than previously stated in the instructions. This happens because the metal components interact with MRI's radiofrequency fields, potentially heating up and causing burns.
Surgical patients and medical facilities using the I.T.S. DUL or UOL systems with specific article numbers. Patients undergoing MRI scans with these systems are at risk of burns.
Check for article numbers: DUL systems include 21232-3 to 21235-4; UOL systems include 21231-6 and 37302-18/20. These products were sold with specific lot numbers.
Identify your product by checking the article numbers and lot numbers listed in the recall notice.
Reach out to I.T.S. GmbH for guidance on next steps if you have the recalled items.
Updated MRI safety testing shows these systems could cause higher temperature increases than previously stated in the instructions, potentially leading to burns during MRI scans.
Check your product's article numbers and lot numbers against the recall list. Contact I.T.S. GmbH for specific guidance.
Yes, the systems could cause burns during MRI scans if not properly managed, but the recall is for safety improvements.
We’ve drafted a message you can send I.T.S. to request your refund or repair — edit it as you like.
Subject: Recall Z-1604-2026 — I.T.S. I.T.S. Hello, I own a I.T.S. that is covered by recall Z-1604-2026 from I.T.S.. 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.
