Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0563-2014·Announced 2014-01-01

Ziehm Solo C-Arm X-Ray System Recalled for Emergency Switch Option

Ziehm Imaging Inc is recalling 58 Solo C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text explicitly describes the issue as a 'minor non-conformity' and the agency classification is Class II. There are no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional component change.

Plain-English summary

Ziehm Imaging Inc is recalling 58 units of the Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. The recall is due to an engineering change implemented in 2006 that resulted in a minor non-conformity. Specifically, the emergency switch was changed from a standard component to an optional feature on the devices.

The affected devices were distributed nationwide in the United States, including Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Montana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming, and Hawaii.

Healthcare facilities should contact Ziehm Imaging Inc for instructions on how to address the non-conformity regarding the emergency switch configuration.

The recalled product

Product: Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Manufacturer: Ziehm Imaging Inc
Category: Medical Device — Imaging Equipment
Hazard: functional-defect
Affected units: 58

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Ziehm Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Ziehm Imaging Inc

See all →

Moderate
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Recalled for Missing Label Date
FDA (Devices) · 2017-05-24
High
Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction
FDA (Devices) · 2016-08-31
High
Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction
FDA (Devices) · 2016-08-31

Same hazard · functional defect