Z-1036-2009

GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane...

Name: Z-1036-2009 GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane...
Creator: GE Medical Systems, LLC
Published: 2008-11-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-11-04 / Terminated

FDA source

GE Medical Systems, LLC began a recall of 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... on 2008-11-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1036-2009
Status: Terminated
Initiated: 2008-11-04
Posted: 2009-09-24
Terminated: 2012-05-16
Recalling firm: GE Healthcare
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 procedures.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: 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%.
FDA root cause: Radiation Control for Health and Safety Act
Action: Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators.
Quantity in commerce: 166
Distribution: Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico.
Product codes and lots: 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.

Product code MQB

K052412Class IIInnova 2100-Iq, Innova 3100, Innova 3100-Iq, Innova 4100, and Innova 4100-IqGE Healthcare / cleared 2005-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)