I.T.S. Straight Plate Recall Due to MRI Safety Issues
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I.T.S. GmbH is voluntarily recalling 510 units of various medical plates because updated MRI safety testing revealed higher temperature increases than previously stated in the instructions.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
I.T.S. GmbH is recalling certain straight plates due to updated MRI safety testing that shows higher RF-induced temperature increases under specific MRI conditions than what was previously indicated in the Instructions for Use (IFU).
Which Products Are Affected
The affected products include: 1. Forearm Plate, Curved with Article Numbers: 21604-6 and 21604-9; 2. Forearm Plate, Straight with Article Numbers: 21605-11, 21605-6, and 21605-9; 3. Straight Compression Plate with Article Numbers: 21105-6 and 21105-8; 4. Straight Plate, 1.5mm with Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, and 21104-9; 5. Straight Plate, 2.0mm with Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, and 21101-13; 6. Straight Plate, 3.5mm with Article Number: 21102-6; and 7. Straight Plate, 4.5mm with Article Numbers: 21103-8, 21103-9, 21103-10, 21103-11, 21103-12, and 21103-13. The recall involves a total of 510 units distributed nationwide in the United States, specifically in states including AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, and W. The affected lots are detailed by article number, such as 21604-6 with lots 643/052301, 643/0652, and 643/092201. The official recall number is Z-1598-2026.
What You Should Do
Consumers who have been notified via e-mail by the firm should follow the instructions provided in that notification regarding the recall. For further information, contact I.T.S. GmbH at their address: Autal 28, Lasnitzhohe, Austria.
Why This Matters
This recall addresses potential safety risks associated with MRI procedures, ensuring that medical devices meet updated safety standards to prevent possible harm to patients.
Source
Information from the FDA recall database, recall number Z-1598-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,858 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.