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U.S. Department of Health and Human Services

Class 2 Device Recall Actiwatch 16

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 Class 2 Device Recall Actiwatch 16see related information
Date Initiated by FirmJune 27, 2007
Date PostedJanuary 17, 2008
Recall Status1 Terminated 3 on October 20, 2010
Recall NumberZ-0327-2008
Recall Event ID 38368
510(K)NumberK983533 
Product Classification Patient Physiological Monitor - Product Code M HX
ProductActiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00.
Code Information Serial Numbers: V960700, V960703, V960735, V960739, V960740, V960864, V960865, V960866, V960868, V960869, V960870, V961013, V961014, V961015, and V960659.
Recalling Firm/
Manufacturer		 Mini-Mitter Company, Inc.
20300 Empire Ave Ste B3
Bend OR 97701
For Additional Information ContactFrederic Viaud
724-387-7919
Manufacturer Reason
for Recall		Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
FDA Determined
Cause 2		Software design
ActionA Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.
Quantity in Commerce15
DistributionWorldwide
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 = M HX
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