FDA recall Z-0703-2018

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

Reason for recall

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.

Distribution

USA (nationwide) Distribution

Key facts

Status

Terminated

Initiation date

2017-07-31

Report date

2018-03-07

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Freedom, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0703-2018