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.
FDA Recall Z-2143-2008 · Posted 2008-09-19
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-05-01
Date Terminated2011-12-17
Product Quantity54 (24 US / 30 OUS)
Reason for Recall
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.
Firm Action
GE Field Engineers visited affected customers to make the correction.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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