Recall Z-1904-2010 ยท IZO Generator, High-Voltage, X-Ray, Diagnostic
Mallinckrodt Inc
Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.
| Date | Jun 25, 2010 (initiated Jun 14, 2010) |
| Status | Terminated |
| Reason | Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative. |
| Root cause | Process control |
| Action | Covidien Issued an "Urgent Device Correction" notification dated June 14, 2010 informing their customers of the potential problem. Consignees were instructed that Field Service Engineers will be in contact arrange a service visit to perform corrections on the affected units. For further information, contact Covidien Product Monitoring at 1-800-778-7898. |
| Quantity | 144 units |
| Distribution | Worldwide Distribution -- United States, Canada and China. |
| FDA record | Open on fda.gov |