Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
This recall has been terminated (originally issued May 19, 2009).
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- November 21, 2008
- Posted
- May 19, 2009
- Terminated
- November 21, 2013
- Recall Number
- Z-1195-2009
- Quantity
- 85
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag
Distribution
Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy.
Lot / Code Info
Product Number: 2121-IQ; Serial Numbers: 410614CV2, 253627INNOVA5, 808547QCV4, IE1100VA03, 713794LAB11, 936WH2121, 3108252121A, 416480INNOVA2, 3108252121B, 215576INNOVA2, 617636IN2121, 304526INNOVABP, 853060201, 541743CL5, 4105502121, 202782LABA, 857307IN32121, YV0362, YV0369, 610526LAB3, 610954BP1, 612273INNOVA3, 410614CV1, 857307IN12121, 857307IN22121, 319272EP, YV0363, 904202WCL1, 4146492121, FHORLEP4, FHORLEP5, 206598UWBP, 316268BIPLANE and HSRINNOVA1 and Product Number: 3131-IQ; Serial Numbers: 8184093131, 00440VAS04, 509474BIP, 561548BIP, 812238UNBPL, 615222BIH, 303425CL2, 516562INNOVA1, RO1095VA01, 6263973131, YV0462, YV0463, 853060198, 4144473131, BH1000VA01, 5135843131, 507385INN3131, 541382BP, YV0464, M4166990, YV0470, YV0166, 10307VAS01, 317338PV4, 309655FSP4A, YV0466, 773RES3131BP, 309655FSP2B, 713794LAB8, 630933INVLAB4, 518262BP1, 853060202, 00026VAS01, 410740CV, 834160004, 853060200, 301295EP, N4192939, COR373252, 2197383131, 718579INNOVABP, 83016900000000, 816932SL3131, 814877BP, 281637SL3131, 617525IN13131, FHORL3131, A5632421, FDO 0002769264, YV0471 and 834160005.
Root Cause
Device Design
Action Taken
A GE Healthcare "Urgent Medical Device Correction" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Further questions should be addressed to GE Healthcare at 1-800-437-1171.