Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

FDA Recall Z-0911-2014 · Posted 2014-02-03

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2013-12-12
Date Terminated2014-09-11
Product Quantity816 (722 US, 94 OUS).

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will

Firm Action

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated December 11, 2013 to its consignees. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/ Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to immediately contact your local GE Healthcare Service Representative if you observe any inappropriate performance or excessive movement of the monitor suspension yoke. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following numbers: United States: 800-437-1171, Japan: 0120-055-919, for other countries contact your local GE Healthcare Service Representative.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM, VENEZUELA, and YEMEN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082243PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMSGeneral Medical Merate S.P.A · 2008-11-07K081091PRECISION 500D R&F X-RAY SYSTEMGE Healthcare · 2008-06-11K033486GE PRECISION MPINrt-Nordisk Rontgen Teknik A/S · 2003-11-19

Official Source

View FDA Recall →

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

↑