FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
- Recall number
- Z-0138-2010
- Recalling firm
- GE Medical Systems, LLC
- Product
- Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
- Status
- Terminated
- Initiated
- 2009-04-16
- Posted
- 2009-11-09
- Terminated
- 2015-12-03
- Reason
- Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
- Root cause
- Device Design
- Action
- Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
- Quantity
- 15 AND 46 UNLOCATED
- Distribution
- Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
- Lot, serial or model codes
- SYSTEM ID: 0847160005 542120XR02 561548BIP 561881BP1 630856H3131 817465AR3131 985867INNOVA31 COR373301 EG1000VA01 LY1086VA01 M4166990 05448VAS01 VAD2121 YE1002VA01 YV0365 NOT LOCOLIZED S/N CHILLER 798080-21 796259-09 794637-08 795371-01 796133-12 796259-05 796464-08 796464-13 796464-15 796767-05 796941-03 796941-04 796941-07 796941-09 797178-05 797179-03 797179-08 797179-12 797449-03 797449-06 797632-02 797812-04 797812-09 797812-10 797812-12 767326-03 770355-02 772153-13 767746-05 785678-16 794637-11 799172-07 799347-03 799347-05 796260-01 783679-01 797178-03 797179-07 797179-09 797179-11 797812-14 797812-16 799347-02 798449-01 798449-02 798449-03
- 510(k) numbers
- ["K060259","K061163"]
- PMA numbers
- not on file
- Product code
- JAA
- 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