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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn Acuity Central Monitoring Station

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 Class 2 Device Recall Welch Allyn Acuity Central Monitoring Stationsee related information
Date Initiated by FirmDecember 31, 2003
Date PostedFebruary 13, 2004
Recall Status1 Terminated 3 on January 06, 2005
Recall NumberZ-0538-04
Recall Event ID 28003
510(K)NumberK022453 
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
ProductWelch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
Code Information CPU Serial Numbers: LT00001-LT000015, LT000017-LT000019, TA00274, TA00415, TA00415-HA, TA00468, TA00554, TA00582, TA 00587, TA00587-HA, TA00639, TA00738, TA00745, TA00854, TA00856, TA00861, TA00880, TA00889, TA00891, TA01200, TA01217, TA01218, TA01253, TA01278, TA01279, TA01286, TA01304, TA01306, TA01327, TA01359, TA01359-HA, TA01387, TA01387-HA, TA01388-TA01398, TA01391HA, TA01400-TA01411, TA01413-TA01423, TA01426-TA01435, TA01433-HA, TA01438--TA01446, TA01448-TA01455, TA01453-HA, TA01457-TA01461, TA01463, TA01463-HA, TA01464, TA01466-TA01469, TA01471-TA01480, TA01473-HA, TA01478-HA, TA01481-HA, TA01482-TA01486, TA01484-HA, TA01485-HA, TA01488, TA01488-HA, TA01490-TA01493, TA01493-HA, TA01499-TA01515, TA01508-HA, TA01509-HA, TA01510-HA, TA01515-HA, TA01517-TA01526, TA01522-HA, TA01523-HA, TA01525-TA01528, TA01530-TA01546, TA01534-HA, TA01535-HA, TA01536-HA, TA01537-HA, TA01544-HA, TA01548-TA01550, TA01552--TA01561, TA01561-HA, TA01563-TA01570, TA01567-HA, TA01568-HA, TA01574.
FEI Number 3023750
Recalling Firm/
Manufacturer		 Welch Allyn Protocol, Inc
8500 SW Creekside Pl
Beaverton OR 97008-7107
For Additional Information ContactMarvin T. Iglehart
503-530-7909
Manufacturer Reason
for Recall		Potential failure to audibly alarm due to speaker hardware component failure.
FDA Determined
Cause 2		Other
ActionThe firm sent a letter dated December 31, 2003 instructing their customers to install an audio cable from the CPU to the Flat Panel Monitor to provide redundant speaker capability. The audio cable and installation instructions were included in the letter. The letter also included a Correction Response Form which customers should fill out upon completion of correction.
Quantity in Commerce233 devices
DistributionThe firm distributes the product nationwide and internationally.
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.
510(K) Database510(K)s with Product Code = DSI
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