| Class 2 Device Recall Hydradjust IV DR Urological Table Sedecal Generator | |
Date Initiated by Firm | June 14, 2010 |
Date Posted | June 25, 2010 |
Recall Status1 |
Terminated 3 on February 25, 2012 |
Recall Number | Z-1904-2010 |
Recall Event ID |
55953 |
510(K)Number | K920742 K943581 |
Product Classification |
Generator, high-voltage, x-ray, diagnostic - Product Code IZO
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Mallinckrodt Inc 2111 E Galbraith Rd Cincinnati OH 45237-1624
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For Additional Information Contact | 513-948-5719 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IZO
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