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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 4100/4100IQ GE Innova 4100 / 4100 IQ.

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  Class 2 Device Recall Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. see related information
Date Initiated by Firm August 05, 2009
Date Posted November 17, 2010
Recall Status1 Terminated 3 on January 16, 2014
Recall Number Z-0410-2011
Recall Event ID 56967
510(K)Number K061163  K052157  K052412  
Product Classification Solid state x-ray image (flat panel/digital imager) - Product Code MQB
Product Innova 4100/4100IQ 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 Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Code Information 4100IQ 00065VAS01 06014VAS01 10497VAS01 207662OR4100 215537INNOVA1 215662INNOVA1 216778ANGIO1 216778ANGIO2 2198864100 228809VASC 229312IN41OR 239939INNOVA 248849SP1 248937IN1 256429SV1 281401T4100 303399IR 304347INNOVA2 305835IN41 309343CSP1A 309655FSP1A 309655FSP3A 309672MCL2 314966DPHSP 316962INNOVA41 317621PV 317887INNOVAPV 318681INNOVA1 330489ORVASC 386HPOS1 404466SF41A 404712SP12 404712SP13 409212INOV41 410337INNOVA2 412641IR 412784LAB1 412784LAB2 414649DVI 419557ORLAB 423495ENDO2 4436434100 4438434100 478765ANG1 480512SP 505848V4100 508650IN41 509474SH41 509575YM4100 512528CPCL1 512901NI4100 516632INNOVA8 561548VAS2 561776IN41 561784INSP 570321LAB2 574647IN2 586573SP1 6012884100SUR 609757IN4100 614722INNOVA1 615284OR15 615342CV7 620665INNOVA41 623848SP 630275G41 630275G41B 661BHINNOVA4 7023604100 706651SP1 706733SP1 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100 718250ANGIO 724773C4 727398SPEC1 731541RD 770736SP1 802295VALCA 814889SP 817465AR4100 817922BA4100 843577CL2 843674VAS1 843674VAS2 843789SP1 843797TIR2 847316INNOVA41 847316INNOVA41 858939IR9 8593134100 85931341002 864573LAB2 865481SUR 904202SPS 906485ANGIO 910907WAVAS1 915577SP1 915577SP2 937352IN4100 A5123529 A5123529 A56364110 DE188442 DE641223 DR4100 HC0220XR07 MCL4100 NO1017VA03 NO1018VA02 NO1037VA01 NO1064VA04 RADNETXV2 RU1283VA01 RU3293VA01                                                                                                          
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power. UPS fluoro ba
FDA Determined
Cause 2		 Nonconforming Material/Component
Action GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.
Quantity in Commerce 117
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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