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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
GE Medical Systems, LLC is recalling GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a va due to Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026