Z-0753-2016 Class II Terminated
FDA device recall Z-0753-2016 was initiated by Regulatory Insight, Inc on July 1, 2008 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 11, 2017). Affected quantity: 43.
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2016
- Initiation Date
- July 1, 2008
- Termination Date
- July 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43
Product Description
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.
Reason for Recall
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.
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.
Code Information
NRT no.: 02980000