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Terminated

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.

FDA Recall Z-1904-2010 · Posted 2010-06-25

Recalling FirmMallinckrodt Inc
Recall StatusTerminated
Product CodeIZO
Date Initiated2010-06-14
Date Terminated2012-02-25
Product Quantity144 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States, Canada and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943581HYDRADJUST IV UROLOGICAL TABLEMallinckrodt Group, Inc. · 1995-01-04K920742HYDRAJUST IV UROLOGICAL TABLEMallinckrodt Group, Inc. · 1992-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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