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.
FDA Recall Z-2183-2011 · Posted 2011-05-11
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Recalling FirmRemote Diagnostic Technologies Ltd.
Recall StatusTerminated
Product CodeMWI
Date Initiated2011-03-25
Date Terminated2011-09-16
Product Quantity19 units
Reason for Recall
It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution -- KY, MD, VA, and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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