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

FDA device recall Z-1989-2013 · posted 2013-08-20 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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

Action taken

GE Healthcare "Urgent Medical Device Correction" letter dated May 1, 2013 to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter informed customers that GE Healthcare will correct all affected systems at no cost. A GE Healthcare service representative will contact you to arrange for this correction. For questions or concerns regarding this notification call: US 800-437-1171, Japan: 0120-055-919.

Root cause

Device Design

Status

Terminated

Product code

JAA

Quantity 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,

Date initiated

2013-05-02

Date posted

2013-08-20

Date terminated

2013-11-26

Location

Waukesha, WI

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