Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrod
FDA device recall Z-1904-2010 · posted 2010-06-25 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZO
- Quantity affected
- 144 units
- Distribution
- Worldwide Distribution -- United States, Canada and China.
- Date initiated
- 2010-06-14
- Date posted
- 2010-06-25
- Date terminated
- 2012-02-25
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDRADJUST IV UROLOGICAL TABLE (K943581) | Mallinckrodt Group, Inc. | 1995-01-04 |
| HYDRAJUST IV UROLOGICAL TABLE (K920742) | Mallinckrodt Group, Inc. | 1992-04-27 |