Z-1155-2009

GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

Name: Z-1155-2009 GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
Creator: Ge Healthcare
Published: 2009-02-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-02-19 / Terminated

FDA source

Ge Healthcare began a recall of GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System on 2009-02-19. The reason FDA records is "The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1155-2009
Status: Terminated
Initiated: 2009-02-19
Posted: 2009-09-24
Terminated: 2011-07-22
Recalling firm: GE Healthcare
Product: GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.
Quantity in commerce: 554 units
Distribution: Worldwide Distribution
Product codes and lots: n/a

Product code JAA

K043076Class IIGe Oec FluorostarGe Oec Medical Systems, Inc. / cleared 2004-12-22

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)