—#84852

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.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052412
Affected lot / code info: 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.

Why it was recalled

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%.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-11-04
Posted by FDA: 2009-09-24
Terminated: 2012-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84852. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.