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Terminated

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

FDA Recall Z-2179-2017 · Posted 2017-05-22

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIXR
Date Initiated2017-02-06
Date Terminated2018-03-02
Product Quantity2,380 (2,215 US; 165 OUS)

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.

Firm Action

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

Distribution Pattern

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, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081091PRECISION 500D R&F X-RAY SYSTEMGE Healthcare · 2008-06-11K011624EXPEDIO 500D R&F X-RAY SYSTEMGE Medical Systems · 2001-06-08K973039LEGACY/LEGACY-D TABLEGE Medical Systems · 1997-10-16K862120SCX SYSTEMGeneral Electric Co. · 1986-06-16K801320SFX-90 TABLE/SPOTFILMER W/FLUORICON L200General Electric Co. · 1980-07-21K760466TABLE, X-RAY, RFX CLASSICALGeneral Electric Co. · 1976-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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