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U.S. Department of Health and Human Services

Class 2 Device Recall TEMPUS IC PROFESSIONAL

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 Class 2 Recall
TEMPUS IC PROFESSIONAL
see related information
Date Posted May 11, 2011
Recall Status1 Terminated on September 16, 2011
Recall Number Z-2183-2011
Recall Event ID 58479
Premarket Notification
510(K) Number
K101264 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.
Code Information Identification Numbers: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020.
Recalling Firm/
Manufacturer
Remote Diagnostic Technologies Ltd.
The Old Coach House, The Av.
Farleigh Wallop, Basingstoke
Hampshire
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Remote Diagnostic Technologies, Ltd notified its consignees of the problem and the work-around via letter with the subject line "ECG Issue - Field Action Required" on 03/25/2011. The letter stated that customers can avoid the issues by viewing the recorded ECG for at least 13 seconds. Two diagrams were attached with the letter depicting the conditions under which the issue can occur. Customers can continue to use the device normally in all other respects. The letter states that the firm is working on a software modification which will permanently fix the issue and prevent it from occurring. Customers are to contact the Regulatory Affairs and Operations Manager if they have any questions.
Quantity in Commerce 19 units
Distribution Nationwide Distribution -- KY, MD, VA, and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
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