Company: Regulatory Insight, Inc.
Date of Enforcement Report 3/2/2016
Class lI:
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. Recall Number Z-0753-2016
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.
RECALLING FIRM/MANUFACTURER
Regulatory Insight, Inc., Littleton, CO 2/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
43
DISTRIBUTION
Nationwide
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