Medical device recalls Moderate risk

Oakworks Inc recalls Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 I…

Recall date
July 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0703-2018
FDA classification
Class II
Brand / firm
Oakworks Inc
Sold / distributed
USA (nationwide) Distribution

Why it was recalled

The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿ Medical CFUR 401 Urology Table OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table

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