Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Advertisement
Recall Number
Z-1595-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-23
Reported
2026-04-01
Distribution
US Nationwide distribution in the states of 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, W.
Code Info
Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.