Z-1394-04

SMV FX-80 Nuclear Camera

Name: Z-1394-04 SMV FX-80 Nuclear Camera
Creator: General Electric Med Systems
Published: 2004-07-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-07-30 / Terminated

FDA source

General Electric Med Systems began a recall of SMV FX-80 Nuclear Camera on 2004-07-30. The reason FDA records is "The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1394-04
Status: Terminated
Initiated: 2004-07-30
Posted: 2004-08-24
Terminated: 2006-07-24
Recalling firm: GE Healthcare
Product: SMV FX-80 Nuclear Camera
Product code: IYX Camera, Scintillation (Gamma)
Reason for recall: The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.
FDA root cause: Other
Action: The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out.
Quantity in commerce: 41
Distribution: Inside the US. Manufactured and distributed from 1993 - 2000.
Product codes and lots: 00000000000172, 00000000000173, 00000000000188, 00000000000203, 00000000000209, 00000000000214, 00000000000223, 0070090080-103, 0070090080-106, 0070090080-107, 0070090080-112, 0070090080-115, 0070090080-116, 0070090080-123, 0070090080-124, 0070090080-125, 0070090080-126, 0070090080-127, 0070090080-138, 0070090080-141, 0070090080-146, 0070090080-150, 0070090080-152, 0070090080-158, 0070090080-161, 0070090080-162, 0070090080-163, 0070090080-164, 0070090080-165, 0070090080-167, 0070090080-168, 0070090080-170, 0070090080-172, 0070090080-173, 0070090080-179, 0070090080-180, 0070090080-188, 0070090080-203, 0070090080-209, 0070090080-96, 0070090080-P298

Product code IYX

K935273Class IVision Fx 40 & 80 Series Gamma CameraSummit Nuclear / cleared 1994-04-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)