Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Reason: There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

Code information: Model Number 5771387; System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B3-18-014); 951486RU630 (B3-18-009, 01008406821246141118040021B3-18-009); 714993IGS630 (B3-18-004, 01008406821246141118020021B3-18-004); 906225EP1 (B3-18-015, 01008406821246141118070021B3-18-015); 906225CATH4 (B3-18-016, 01008406821246141118080021B3-18-016); 843797IGS30 (B3-18-030, 01008406821246141119010021B3-18-030); 4603984XV41 (B3-18-019, 01008406821246141118090021B3-18-019); MCARIGS630 (B3-18-008, 01008406821246141118040021B3-18-008); 509473RM1B (B3-18-028, 01008406821246141119010021B3-18-028); 414649IGS8 (B3-18-020, 01008406821246141118090021B3-18-020); HU1099VA07 (B3-18-024, 01008406821246141118110021B3-18-024); A670060221 (B3-19-002, 01008406821246141119020021B3-19-002); A5163326 (B3-18-007, 01008406821246141118030021B3-18-007); YV4504 (B3-18-018, 01008406821246141118090021B3-18-018); YV4505 (B3-18-027, 01008406821246141118120021B3-18-027); YV4507 (B3-18-022, 01008406821246141118110021B3-18-022); 0850060762 (B3-18-025, 01008406821246141118110021B3-18-025); 0850060763 (B3-18-026, 01008406821246141118120021B3-18-026); KW1155VA02 (B3-18-017, 01008406821246141118080021B3-18-017); PL1689VA01 (B3-18-021, 01008406821246141118100021B3-18-021); PL0302VA02 (B3-18-011, 01008406821246141118060021B3-18-011); 06189VAS11 (B3-18-029, 01008406821246141119010021B3-18-029)

Distribution pattern: Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.