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Class 2 Device Recall Epic |
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Date Initiated by Firm |
January 17, 2006 |
Date Posted |
March 31, 2006 |
Recall Status1 |
Terminated 3 on July 03, 2006 |
Recall Number |
Z-0554-06 |
Recall Event ID |
34486 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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Product |
Stryker Epic Critical Care Bed; Model 2030. |
Code Information |
Serial numbers 0512068638, 0512068639, 0512068640, 0512068641, 0512068642, 0512068667, 0512068668, 0512068669, 0512068670, 0512068725, 0512068726, 0512068727, 0512068728, 0512068740, 0512068750, 0512068751, 0409060679, 0409060680, 0409060681, 0409060682, 0409060683, 0409060684, 0409060685, 0409060686, 0409060687, 0512068643, 0512068644, 0512068645, 0512068646, 0512068647, 0512068648, 0512068649, 0512068650, 0512068651, 0512068652, 0512068653, 0512068654, 0512068655, 0512068656, 0512068657, 0512068658, 0512068659, 0512068660, 0512068661, 0512068662, 0512068779, 0512068780, 0512068781, 0512068782, 0512068783, 0512068784, 0512068785, 0512068709, 0512068710, 0512068711, 0512068712, 0512068713, 0512068714, 0512068715, 0512068716, 0512068717, 0512068718, 0512068719, 0512068720, 0512068721, 0512068722, 0512068723 and 0512068724. |
Recalling Firm/ Manufacturer |
Stryker Medical 6300 Sprinkle Rd Kalamazoo MI 49001
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For Additional Information Contact |
269-324-6689
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Manufacturer Reason for Recall |
The bed exit may not alarm as appropriate.
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FDA Determined Cause 2 |
Other |
Action |
The firm began visiting accounts to install new software on 1/17/06 and expects completion of installation at all accounts by 3/31/06. |
Quantity in Commerce |
68 |
Distribution |
World Wide--(Chile, Mexico and Singapore) |
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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