FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Recall number
- Z-0137-2010
- Recalling firm
- GE Medical Systems, LLC
- Product
- GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- 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
- 35
- 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: 80158241 06014VAS01 06063VAS01 082406100018 0828160011 205759CL2 207662OR4100 215662INNOVA1 216844INNOVA 228809VASC 22925941V2 309672M4100 414649DVI 508383IN4100 509575YM4100 6012884100SUR 715369INN4100 718518CVL1 801268INNOVA 812825INNOVA1 843789SP1 865373SP 865541CCL5 904BSSP 910907WAVAS1 9408984100 A56364110 BG4037XR01 HC1819XR09 HC2001XR02 M2030711 NO1017VA03 NO1064VA04 RU2526VA01 XF0160
- 510(k) numbers
- ["K023178","K033244","K042053","K052157","K052412","K061163"]
- PMA numbers
- not on file
- Product code
- IYO
- 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