Events

Recall of Device Recall Digital Fluoroscopic Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53176
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-2009
  • Event Initiated Date
    2008-11-04
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84852
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid State X-Ray Imager - Product Code MQB
  • Reason
    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%.
  • Action
    Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators.

Device

Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    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 Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA