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Recall Observatory FDA recall evidence

Device 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

Z-0703-2018

July 31, 2017

Class II

Product summary

Firm
Oakworks Inc
Event
Event 79107
Status
Terminated
Classification
Class II
Quantity
1,104
Official record key
device-enforcement:Z-0703-2018

Official wording

Reason: 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.

Code information: MODEL #(s): "CFPM 300 "CFPM 301 "CFPM 400 "CFPM 401 "CFPMB 301 "CFUR 301 "CFUR 401 "CFLU 401 CATALOG #(s): "75208-T01 and 75209-T01 "75211-T01 and 75212-T01 "75204-T01 and 75205-T01 "75206-T01 and 75207-T01 "75213-T01 "75214-T01 "75215-T01 "75216-T01

Distribution pattern: USA (nationwide) Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.