FDA Device Recall Z-2183-2011: Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom

Recall Parameters & Description

Normalized public record details for FDA recall code Z-2183-2011.

Recall Res Number

Z-2183-2011

Recalling Firm / Manufacturer

Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom

FEI Number

3003832357

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-03-25

Date Posted

2011-05-11

Date Terminated

2011-09-16

Product Code

MWI

Event Number

58479

Product Quantity

19 units

Product Description 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.

Reason for Recall It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.

Action Details 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.

Distribution Pattern Nationwide Distribution -- KY, MD, VA, and FL.

Code Information / Serial Numbers Identification Numbers: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020.

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Medical Device Recall: Z-2183-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer