FDA Medical Device Recalls (openFDA)
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 procedures.
- Recall number
- Z-1036-2009
- Recalling firm
- GE Medical Systems, LLC
- 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.
- Status
- Terminated
- Initiated
- 2008-11-04
- Posted
- 2009-09-24
- Terminated
- 2012-05-16
- 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%.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K052412"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28