510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1904-2010

Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator)...

Mallinckrodt, Inc. / initiated 2010-06-14 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Mallinckrodt Inc began a recall of Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1904-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mallinckrodt, Inc.
Product
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.
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
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.
Root cause tag
manufacturing process
FDA 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 in commerce
144 units
Distribution
Worldwide Distribution -- United States, Canada and China.
Product codes and lots
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.