Class 2 Device Recall TEMPUS IC PROFESSIONAL

• Date Initiated by Firm: March 25, 2011
• Date Posted: May 11, 2011
• Recall Status: Terminated on September 16, 2011
• Recall Number: Z-2183-2011
• Recall Event ID: 58479
• 510(K)Number: K101264
• Product Classification: Physiological Patient Monitor (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 United Kingdom
• 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: 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 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) Database: 510(K)s with Product Code = MWI