—#65748

Product

GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042053
Affected lot / code info: 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH, 414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41, 516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41, 6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA, 614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA, 7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31, 717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1, 727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH, 808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA, 813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19, 850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3, 904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1, 936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1, 973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04, RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036.

Why it was recalled

Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a c

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed at their site at no cost.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia.

Timeline

Recall initiated: 2007-10-21
Posted by FDA: 2008-09-29
Terminated: 2011-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.