FDAFDA · Food and drugs·Recall number Z-0753-2016
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Published March 2, 2016 · Recall initiated: July 1, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Regulatory Insight, Inc
- Distributor
- US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
- Lot
- NRT no.: 02980000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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