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Recall Observatory FDA recall evidence

Device product

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.

Z-0753-2016

July 01, 2008

Class II

Product summary

Firm
Regulatory Insight, Inc
Event
Event 72515
Status
Terminated
Classification
Class II
Quantity
43
Official record key
device-enforcement:Z-0753-2016

Official wording

Reason: 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.

Code information: NRT no.: 02980000

Distribution pattern: US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.