Recall Z-1989-2013— GE Healthcare, LLC

Name: FDA recall Z-1989-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-02

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-05-02, terminated 2013-11-26. It names one FDA 510(k) clearance: K011624. Product: GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.. Reason: GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-05-02
Terminated: 2013-11-26
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K011624 — EXPEDIO 500D R&F X-RAY SYSTEMGE Medical Systems·cleared 2001-06-08

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, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and

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