PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 28, 2013 Initiated: May 2, 2013 #Z-1989-2013

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
445 (421 US, 24 OUS)
Distribution
Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.. Recalled by GE Healthcare, LLC. Units affected: 445 (421 US, 24 OUS).
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-1989-2013.