Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
FDA Recall Z-0157-03 · Posted 2003-02-12
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Recalling FirmGeneral Electric Med Systems
Recall StatusTerminated
Product Code90LMA
Date Initiated2002-11-21
Date Terminated2004-07-02
Product Quantity78 devices
Reason for Recall
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
Firm Action
Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment.
Root Cause
Other
Distribution Pattern
The product had been shipped to hospitals located nationwide in the United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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