Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

FDA device recall Z-2179-2017 · posted 2017-05-22 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.

Action taken

Consignees were sent on 2/6/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10908 dated February 3rd, 2017. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator & Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact consignee to arrange for the correction.. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Terminated

Product code

IXR

Quantity affected

2,380 (2,215 US; 165 OUS)

Distribution

US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Ital

Date initiated

2017-02-06

Date posted

2017-05-22

Date terminated

2018-03-02

Location

Waukesha, WI

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