FDA Recall
Terminated
Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
Recall: Z-0157-03
·
Initiated November 21, 2002
Recall
- Recall Number
- Z-0157-03
- Event Number
- 25531
- Firm
- General Electric Med Systems
- FEI Number
- 2126677
- Product Code
- 90LMA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 21, 2002
- Posted
- February 12, 2003
- Terminated
- July 2, 2004
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53186
Description
Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
Reason
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
Action
Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment.
Distribution
The product had been shipped to hospitals located nationwide in the United States.
Quantity
78 devices