FDA Medical Device Recalls (openFDA)
General Electric Med Systems: Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
- Recall number
- Z-0157-03
- Recalling firm
- General Electric Med Systems
- Product
- Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
- Status
- Terminated
- Initiated
- 2002-11-21
- Posted
- 2003-02-12
- Terminated
- 2004-07-02
- Reason
- The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
- Root cause
- Other
- Action
- Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment.
- Quantity
- 78 devices
- Distribution
- The product had been shipped to hospitals located nationwide in the United States.
- Lot, serial or model codes
- All serial numbers in distribution at the time of the recall.
- 510(k) numbers
- ["K012389"]
- PMA numbers
- not on file
- Product code
- 90LMA
- 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