FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
- Recall number
- Z-0621-2010
- Recalling firm
- GE Medical Systems, LLC
- Product
- Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
- Status
- Terminated
- Initiated
- 2009-12-22
- Posted
- 2010-01-13
- Terminated
- 2015-11-13
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 21
- Distribution
- Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
- Lot, serial or model codes
- 206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 3108252121A 4146492121 541743CL5 617636IN2121 713794LAB11 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 0853060201 YV0363 YV0365 YV0369 IE1100VA03 05448VAS01 HSRINNOVA1 416480INNOVA2
- 510(k) numbers
- ["K061163"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28