GE Medical Systems, LLC GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional p Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional p
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
system ID: 201541SP1, 207662OR4100, 209467INNOVA308, 212639ANI4100, 215537INNOVA1, 215662INNOVA1, 216778ANGIO1, 216778ANGIO2, 2198864100, 228809VASC, 229312IN41OR, 229434INNOV, 239939INNOVA, 248849SP1, 248937IN1, 252847PRS2, 252847PRS3, 256429SV1, 281401T4100, 303399IR, 303436ANGIO, 303436ANGIO2, 304256INNOVA, 304347INNOVA2, 304424CCINOVA, 3046234100, 305823IN4100, 305835IN41, 309343CSP1A, 309655FSP1A, 309655FSP3A, 309672MCL2, 313343SP1, 314966DPHSP, 316651INNOVA41, 316962INNOVA41, 317621PV, 317887INNOVAPV, 318681INNOVA1, 330489ORVASC, 330489SPEC9, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404712SP12, 404712SP13, 404GHSIR1, 404GHSIR2, 409212INOV41, 410337INNOVA2, 412641IR, 412647OR10, 412784LAB1, 412784LAB2, 4134474100, 4135344100, 414649CL2, 414649DVI, 419557ORLAB, 423495ENDO2, 423495MSPEC2, 443481ANGIO1, 4436434100, 4438434100, 478765ANG1, 480512SP, 5033704100, 505848CATH2, 505848V4100, 508650IN41, 509474SH41, 509482HFI, 509575YM4100, 512528CPCL1, 512901NI4100, 5135844100, 516632INNOVA8, 530888ANG206, 541686SPR1, 561548VAS2, 561694IN1, 561776IN41, 561784INSP, 570321LAB2, 574294IN41, 574647IN2, 586573SP1, 6012884100SUR, 601376SP4100, 609757IN4100, 614722INNOVA1, 615284OR15, 615342CV7, 617636IN1, 618549CM4100, 620665INNOVA41, 623207SP, 623848SP, 630275G41, 630275G41B, 6309784100, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 7023604100, 706651SP1, 706733SP1, 706774USP3, 708202VA41, 7087564100, 708783CL4100, 708783SP4100, 713375U4100, 7137764100, 718250ANGIO, 718630LIBERTY, 727398SPEC1, 731541RD, 740592INNOVA, 770736SP1, 787620IN4100, 8014794100, 802295VALCA, 803256SP, 804320CATH2B, 812238UN41, 812825INNOVA1, 813745INTV, 813972INTV, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 843674VAS1, 843674VAS2, 843789SP1, 843797TIR2, 8458584100, 847316INNOVA41, 850747IN4100, 858939IR9, 8593134100, 85931341002, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 904BSSP, 906485ANGIO, 912819SP1, 913317SLS4100, 915577SP1, 915577SP2, 918494SFSP41, 918682IN41, 918744JR4100, 937352IN4100, 970247INNOVA, 989466INNOVA, COR359867, DR4100, MCL4100, PEMBROKE4100, RADNETXV1, and RADNETXV2.
Products Sold
system ID: 201541SP1, 207662OR4100, 209467INNOVA308, 212639ANI4100, 215537INNOVA1, 215662INNOVA1, 216778ANGIO1, 216778ANGIO2, 2198864100, 228809VASC, 229312IN41OR, 229434INNOV, 239939INNOVA, 248849SP1, 248937IN1, 252847PRS2, 252847PRS3, 256429SV1, 281401T4100, 303399IR, 303436ANGIO, 303436ANGIO2, 304256INNOVA, 304347INNOVA2, 304424CCINOVA, 3046234100, 305823IN4100, 305835IN41, 309343CSP1A, 309655FSP1A, 309655FSP3A, 309672MCL2, 313343SP1, 314966DPHSP, 316651INNOVA41, 316962INNOVA41, 317621PV, 317887INNOVAPV, 318681INNOVA1, 330489ORVASC, 330489SPEC9, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404712SP12, 404712SP13, 404GHSIR1, 404GHSIR2, 409212INOV41, 410337INNOVA2, 412641IR, 412647OR10, 412784LAB1, 412784LAB2, 4134474100, 4135344100, 414649CL2, 414649DVI, 419557ORLAB, 423495ENDO2, 423495MSPEC2, 443481ANGIO1, 4436434100, 4438434100, 478765ANG1, 480512SP, 5033704100, 505848CATH2, 505848V4100, 508650IN41, 509474SH41, 509482HFI, 509575YM4100, 512528CPCL1, 512901NI4100, 5135844100, 516632INNOVA8, 530888ANG206, 541686SPR1, 561548VAS2, 561694IN1, 561776IN41, 561784INSP, 570321LAB2, 574294IN41, 574647IN2, 586573SP1, 6012884100SUR, 601376SP4100, 609757IN4100, 614722INNOVA1, 615284OR15, 615342CV7, 617636IN1, 618549CM4100, 620665INNOVA41, 623207SP, 623848SP, 630275G41, 630275G41B, 6309784100, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 7023604100, 706651SP1, 706733SP1, 706774USP3, 708202VA41, 7087564100, 708783CL4100, 708783SP4100, 713375U4100, 7137764100, 718250ANGIO, 718630LIBERTY, 727398SPEC1, 731541RD, 740592INNOVA, 770736SP1, 787620IN4100, 8014794100, 802295VALCA, 803256SP, 804320CATH2B, 812238UN41, 812825INNOVA1, 813745INTV, 813972INTV, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 843674VAS1, 843674VAS2, 843789SP1, 843797TIR2, 8458584100, 847316INNOVA41, 850747IN4100, 858939IR9, 8593134100, 85931341002, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 904BSSP, 906485ANGIO, 912819SP1, 913317SLS4100, 915577SP1, 915577SP2, 918494SFSP41, 918682IN41, 918744JR4100, 937352IN4100, 970247INNOVA, 989466INNOVA, COR359867, DR4100, MCL4100, PEMBROKE4100, RADNETXV1, and RADNETXV2.
GE Medical Systems, LLC is recalling GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane due to One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%.
Recommended Action
Per FDA guidance
Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators.
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