Z-0157-03

Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems

Name: Z-0157-03 Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
Creator: General Electric Med Systems
Published: 2002-11-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2002-11-21 / Terminated / root cause: labeling and UDI

FDA source

General Electric Med Systems began a recall of Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems on 2002-11-21. The reason FDA records is "The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0157-03
Status: Terminated
Initiated: 2002-11-21
Posted: 2003-02-12
Terminated: 2004-07-02
Recalling firm: GE Healthcare
Product: Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
Product code: 90LMA
Reason for recall: The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
Root cause tag: labeling and UDI
FDA 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 in commerce: 78 devices
Distribution: The product had been shipped to hospitals located nationwide in the United States.
Product codes and lots: All serial numbers in distribution at the time of the recall.

Product code 90LMA

K012389Class IIRevolution Xr/d Digital Radiographic Imaging SystemGe Medical Systems, Inc. / cleared 2001-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)