Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
FDA device recall Z-0157-03 · posted 2003-02-12 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems
- Reason for recall
- The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
- Action taken
- Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment.
- Root cause
- Other
- Status
- Terminated
- Product code
- 90LMA
- Quantity affected
- 78 devices
- Distribution
- The product had been shipped to hospitals located nationwide in the United States.
- Date initiated
- 2002-11-21
- Date posted
- 2003-02-12
- Date terminated
- 2004-07-02
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM (K012389) | Ge Medical Systems, Inc. | 2001-08-10 |