Datex Ohmeda, Inc GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
Brand
Datex Ohmeda, Inc
Lot Codes / Batch Numbers
Systems id: 77573841, 80158241, 910063039, 3018774100, 4103374100, 4438494100, 5134754100, 5138534100, 6029234100, 8159374100, 8595724100, 9408984100, 82406010011, 082416130011, 82416130012, 00095VAS07, 205759CL2, 216844INNOVA, 229228INNOV41V, 229434INNOV, 239436CATH1, 251435ICV5, 304255INNOVA, 304347INNOVA, 315448RM4, 315448RM5, 319338VA4100, 325670CATH, 337981INNOVA, 352333VASC, 352376SP, 352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS, 414961INN4100, 478633INOV, 508856OR41, 515263IL4100, 516562INNOVA4, 573632CRA, 573761SMA, 574535IN41, 600050VA01, 6012884100SP1, 606833INNOVA, 609652CATH3, 614293LIBERTY1, 614293LIBERTY2, 704487CR41, 706802FINN, 715369INN4100, 717763INNOVA41, 717763OR4100, 718518CVL1, 724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA, 757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH, 812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100, 828696IN41, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904276SP, 906485ANGIO, 918307SHIN4, 941483INNOVA41, 956632INN4100, A5630803, B5801711, BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100, YV0003.
Products Sold
Systems id: 77573841, 80158241, 910063039, 3018774100, 4103374100, 4438494100, 5134754100, 5138534100, 6029234100, 8159374100, 8595724100, 9408984100, 82406010011, 082416130011, 82416130012, 00095VAS07, 205759CL2, 216844INNOVA, 229228INNOV41V, 229434INNOV, 239436CATH1, 251435ICV5, 304255INNOVA, 304347INNOVA, 315448RM4, 315448RM5, 319338VA4100, 325670CATH, 337981INNOVA, 352333VASC, 352376SP, 352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS, 414961INN4100, 478633INOV, 508856OR41, 515263IL4100, 516562INNOVA4, 573632CRA, 573761SMA, 574535IN41, 600050VA01, 6012884100SP1, 606833INNOVA, 609652CATH3, 614293LIBERTY1, 614293LIBERTY2, 704487CR41, 706802FINN, 715369INN4100, 717763INNOVA41, 717763OR4100, 718518CVL1, 724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA, 757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH, 812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100, 828696IN41, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904276SP, 906485ANGIO, 918307SHIN4, 941483INNOVA41, 956632INN4100, A5630803, B5801711, BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100, YV0003.
Datex Ohmeda, Inc is recalling GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System due to GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to termi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
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
AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WV, WI, PR
Page updated: Jan 10, 2026