FDA Medical Device Recalls (openFDA)
General Electric Med Systems: SMV FX-80 Nuclear Camera
- Recall number
- Z-1394-04
- Recalling firm
- General Electric Med Systems
- Product
- SMV FX-80 Nuclear Camera
- Status
- Terminated
- Initiated
- 2004-07-30
- Posted
- 2004-08-24
- Terminated
- 2006-07-24
- Reason
- 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.
- 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
- 41
- Distribution
- Inside the US. Manufactured and distributed from 1993 - 2000.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K935273"]
- PMA numbers
- not on file
- Product code
- IYX
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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