Recall Z-2291-2014— GE Healthcare, LLC

Name: FDA recall Z-2291-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-25

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-07-25, terminated 2015-02-20. It names one FDA 510(k) clearance: K132261. Product: GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.. Reason: GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Terminated: 2015-02-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)Ge Medical Systems, LLC·cleared 2013-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

Reason for recall

GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported.

Data sourced from openFDA. This site is unofficial and independent of the FDA.