FDA Medical Device Recalls (openFDA)
GE Medical Systems LLC: Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
- Recall number
- Z-0821-2007
- Recalling firm
- GE Medical Systems LLC
- Product
- Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
- Status
- Terminated
- Initiated
- 2006-12-21
- Posted
- 2007-05-22
- Terminated
- 2008-02-24
- Reason
- When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
- Root cause
- Other
- Action
- Visit to each consignee beginning December 21, 2006.
- Quantity
- 6 units
- Distribution
- Product was distributed in the following states: MS, NE, NJ, and, TX
- Lot, serial or model codes
- 973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A
- 510(k) numbers
- ["K052897"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2183553
- 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