Oakworks Medical Imaging Table Foot Controls Recalled for Lodging Hazard
Oakworks Inc. is recalling foot controls for specific medical imaging tables because they can become lodged under the table base or column.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Oakworks Inc. is recalling foot controls used on specific OAKWORKS Medical imaging tables, including the CFPM 300, CFPM 301, CFPM 400, CFPM 401, CFPMB 301, CFUR 301, CFUR 401, and CFLU 401 models. The recall involves 1,104 units distributed nationwide in the United States.
The foot controls are being recalled because they can become lodged under the base or under the column of the table. This mechanical defect poses a potential hazard to users operating the equipment.
The source text does not specify instructions for consumers or healthcare facilities on how to resolve the issue, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table…
- Manufacturer
- Oakworks Inc
- Category
- Medical Device — Imaging Table
- Affected units
- 1,104
Distribution
Distributed nationwide across the United States.
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