Oakworks Lithotripsy Table Recalled for Incorrect Actuator Assembly Error
Oakworks Inc. is recalling three Lithotripsy/Urology Tables due to an assembly error involving incorrect actuators for lateral and longitudinal movements.
What this means for you
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 could compromise patient safety during procedures, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Oakworks Inc. is recalling three units of the CFLU401 Lithotripsy/Urology Table (Catalog Number: 75216-T01). The recall is due to a table assembly error where incorrect actuators were used for the lateral and longitudinal table movements.
The affected units have serial numbers FLL745088, FLL745089, and FLL745090. These devices were distributed nationwide in the United States, specifically within the state of South Carolina. The tables are intended for use with mobile or compact stationary C-arm imaging systems for pain management and urology procedures.
Healthcare facilities should stop using the affected tables and contact Oakworks Inc. for further instructions regarding the recall.
The recalled product
- Product
- OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic
- Manufacturer
- Oakworks Inc
- Category
- Medical Device — Imaging Table
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial numbers:FLL745088
- FLL745089
- and FLL745090.
Distribution
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