GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, an
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled its Innova 2121IQ and Innova 3131IQ cardiovascular X-ray imaging systems due to a potential safety issue that can occur during fluoroscopic acquisition. The systems may experience a loss of usable imaging mode that requires the system to be restarted to recover functionality. A total of 240 systems were affected (133 in the United States and 107 outside the United States), distributed across numerous states and countries worldwide.
The record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Reason for recall: GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to: AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, M Quantity: 240 (133 US and 107 OUS) Lot/code info: System ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOVA2 HSRINNOVA1 82416070010 82416150007 82416210022 82416040046 CS1006VA05 EG1000VA01 M4198064 N4192939 M4166990 M4212443 HC1819XR10 HC5284XR39 542120XR02 HC5284XR38 83016862100448 835160028 IQ1165VA02 IE1100VA03 A5632421 A5102694 A5379605 A5320145 B5114298 A5360408 YV0370 YV0365 YV0364 YV0166 YV0369 YV0473 YV0480 YV0478 YV0475 YV0362 YV0510 YV0474 YV0481 YV0367 YV0477 YV0388 YV0466 YV0500 YV0463 YV0476 YV0464 YV0462 YV0400 YV0366 YV0501 YV0520 YV0363 YV0555 YV0472 YV0471 YV0470 YV0469 YV0468 YV0467 KW1098VA01 KW1098VA02 KW1011VA02 LB1331VA01 LY1086VA01 834160006 834160005 834160004 INNOVA2948687 PL1804VA01 PER18124 RO1095VA01 RU3427VA01 RU2741VA04 RU3847VA01 RU3883VA01 NA SA2253VA01 SA2236VA01 847160005 847160006 850060744 850060739 MEX68922 853060209 853060201 853060200 853060198 853060202 856160010 AE1225VA01 00234VAS02 00095VAS08 05448VAS01 00440VAS04 10086VAS07 10307VAS01 00243VAS02 00026VAS01 256HHCIB1 205877CCL3 480512BP 8184093131 6263973131 415206IBP1X53 3108252121A 3108252121B 909LLUMC2121 661949INNOVA3 650493BIPL 510428BIPL 619543INNOVABP CHLDRNCL1 303436LCLP 303425CL2 2036882121 FHORLEP4 561548BIP 561495DLBIP FHORLEP5 FHORL3131 904202WCL1 561881BP1 561881BP2 808547QCV4 319272EP 208227INNOVA31 630856H3131 630933INVLAB4 309655FSP4A 773RES3131BP 309655FSP2B 219326EP1 812238UNBPL 317338PV4 317338CL4BP 2197383131 2192632121 2198362121 913541OP3131 316268BIPLANE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.