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U.S. Department of Health and Human Services

Class 2 Device Recall Epic

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 Class 2 Device Recall Epicsee related information
Date Initiated by FirmJanuary 17, 2006
Date PostedMarch 31, 2006
Recall Status1 Terminated 3 on July 03, 2006
Recall NumberZ-0554-06
Recall Event ID 34486
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductStryker 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.
FEI Number 1831750
Recalling Firm/
Manufacturer		 Stryker Medical
6300 Sprinkle Rd
Kalamazoo MI 49001
For Additional Information Contact
269-324-6689
Manufacturer Reason
for Recall		The bed exit may not alarm as appropriate.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce68
DistributionWorld Wide--(Chile, Mexico and Singapore)
Total Product Life CycleTPLC Device Report
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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