GE Healthcare GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
Brand
GE Healthcare
Lot Codes / Batch Numbers
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Products Sold
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GE Healthcare is recalling GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used due to The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray per. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
Recommended Action
Per FDA guidance
GE Field Engineers visited affected customers to make the correction.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, WI
Page updated: Jan 10, 2026