CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
Inc.Lithotripsy/Urology Table: CFLU401 recalled by Oakworks
Oakworks is recalling Oakworks Inc.Lithotripsy/Urology Table: CFLU401, distributed nationwide in the US. The recall was initiated on 2 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1411-2019
- FDA event ID
- 82852
- Recalling firm
- Oakworks, New Freedom, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2019
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 2 May 2019 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +21 days |
| 29 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Product as listed by the FDA
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 procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.
Where it was distributed
US Nationwide distribution in the state of SC.
Questions about this recall
Is Inc.Lithotripsy/Urology Table: CFLU401 recalled?
Yes. Oakworks recalled Inc.Lithotripsy/Urology Table: CFLU401 on 2 May 2019. The recall is Class II and its status is Terminated. Recall number Z-1411-2019.
Why was it recalled?
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Which lots are affected?
Serial numbers:FLL745088, FLL745089, and FLL745090.
Where was it sold?
US Nationwide distribution in the state of SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oakworks
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|---|---|---|---|---|---|
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Bed (Emergency Field Bed) recalled by Oakworks | Oakworks | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |