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

Recall number

Z-1516-2008

Recalling firm

GE Healthcare

Product

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

Status

Terminated

Initiated

2007-10-21

Posted

2008-09-29

Terminated

2011-12-17

Reason

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

Nonconforming Material/Component

Action

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.

Quantity

146 total

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

["K042053"]

PMA numbers

not on file

Product code

MQB

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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