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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 08, 2004
Date PostedAugust 10, 2004
Recall Status1 Terminated 3 on June 21, 2006
Recall NumberZ-1333-04
Recall Event ID 29233
Product Classification Oximeter - Product Code DQA
ProductWelch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
Code Information Serial numbers JA000225 through JA002052.
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 speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
FDA Determined
Cause 2		Other
ActionThe firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.
Quantity in Commerce1828 units
DistributionWelch Allyn distributes product to hospitals, physicians and distributors 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.
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