Z-1522-2008

GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System

Name: Z-1522-2008 GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
Creator: Datex - Ohmeda, Inc
Published: 2008-05-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-05-19 / Terminated / root cause: software

FDA source

Datex - Ohmeda, Inc began a recall of GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System on 2008-05-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1522-2008
Status: Terminated
Initiated: 2008-05-19
Posted: 2008-09-30
Terminated: 2016-06-30
Recalling firm: GE Healthcare
Product: GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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).
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 87
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.
Product codes and lots: 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.

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)