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.
- Company
- Mallinckrodt Inc
- Recall Initiated
- June 14, 2010
- Posted
- June 25, 2010
- Terminated
- February 25, 2012
- Recall Number
- Z-1904-2010
- Quantity
- 144 units
- Firm Location
- Cincinnati, OH
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.
Distribution
Worldwide Distribution -- United States, Canada and China.
Lot / Code Info
Part Number: 750732, Serial Numbers: G28619, G28622, G28623, G28625, G28627, G28630, G28633, G28668, G28669, G28679, G28680, G28924, G28926, G28928, G28930, G28939, G28997, G29001, G29002, G29006, G29028, G29029, G29063, G29064, G29065, G29068, G29069, G29070, G29071, G29138, G29141, G29143, G29151, G29155, G29157, G29162, G29234, G29236, G29238, G29242, G29243, G29248, G29257, G29258, G29261, G29265, G29268, G29277, G29814, G30632, G30635, G30852, G30856, G31123, G31128, G31134, G31344, G31347, G31355, G31359, G31435, G31437, G31439, G31440, G31503, G31505, G31609, G31610, G31612, G31614, G31616, G32275, G32279, G32284, G32288, G32290, G32456, G32461, G32463, G32464, G32468, G32470, G32476, G32511, G32516, G32518, G32520, G32523, G32524, G32537, G32541, G32565, G32566, G32568, G32571, G32578, G32644, G32647, G32649, G32650, G32774, G32776, G32778, G32779, G32786, G32912, G32914, G32915 and G32922; Part Number: 750733, Serial Numbers: G29230, G29891, G30029, G30171, G30172, G30174, G30180, G30322, G30325, G30661, G30666, G30799, G30801, G31007, G31010, G31307, G31310, G315881, G32292, G32535, G32771, G32773, G32918, G-32924, G-32976, G329821, G33085, G33086, G33090, G33361, G33874, G33876, G34118, G34128 and G34232.
Root Cause
Process control
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.