GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 3108252121A 4146492121 541743CL5 617636IN2121 713794LAB11 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 0853060201 YV0363 YV0365 YV0369 IE1100VA03 05448VAS01 HSRINNOVA1 416480INNOVA2
GE Medical Systems, LLC is recalling Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System. due to Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ car. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient
Recommended Action
Per FDA guidance
Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, PR
Page updated: Jan 10, 2026