I.T.S. Straight Plate Recall Due to MRI Safety Issues
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 recalls alert 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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.
Source: FDA Official Notice