Recall Z-0157-03 ยท 90L
General Electric Med Systems
Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
| Date | Feb 12, 2003 (initiated Nov 21, 2002) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012389 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM Ge Medical Systems, Inc., Aug 10, 2001 |