GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
This recall has been terminated (originally issued September 30, 2008).
- Company
- Datex Ohmeda, Inc
- Recall Initiated
- May 19, 2008
- Posted
- September 30, 2008
- Terminated
- June 30, 2016
- Recall Number
- Z-1522-2008
- Quantity
- 87
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
Distribution
Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.
Lot / Code Info
Systems id: 77573841, 80158241, 910063039, 3018774100, 4103374100, 4438494100, 5134754100, 5138534100, 6029234100, 8159374100, 8595724100, 9408984100, 82406010011, 082416130011, 82416130012, 00095VAS07, 205759CL2, 216844INNOVA, 229228INNOV41V, 229434INNOV, 239436CATH1, 251435ICV5, 304255INNOVA, 304347INNOVA, 315448RM4, 315448RM5, 319338VA4100, 325670CATH, 337981INNOVA, 352333VASC, 352376SP, 352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS, 414961INN4100, 478633INOV, 508856OR41, 515263IL4100, 516562INNOVA4, 573632CRA, 573761SMA, 574535IN41, 600050VA01, 6012884100SP1, 606833INNOVA, 609652CATH3, 614293LIBERTY1, 614293LIBERTY2, 704487CR41, 706802FINN, 715369INN4100, 717763INNOVA41, 717763OR4100, 718518CVL1, 724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA, 757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH, 812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100, 828696IN41, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904276SP, 906485ANGIO, 918307SHIN4, 941483INNOVA41, 956632INN4100, A5630803, B5801711, BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100, YV0003.
Root Cause
Software design
Action Taken
An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.