Z-2183-2011

TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies...

Name: Z-2183-2011 TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2011-03-25
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2011-03-25 / Terminated

FDA source

Remote Diagnostic Technologies Ltd. began a recall of TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants... on 2011-03-25. The reason FDA records is "It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2183-2011
Status: Terminated
Initiated: 2011-03-25
Posted: 2011-05-11
Terminated: 2011-09-16
Recalling firm: Remote Diagnostic Technologies Ltd.
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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 root 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.
Product codes and lots: Identification Numbers: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020.

Product code MWI

K101264Class IITempus Ic Professional Patient MonitorRemote Diagnostic Technologies , Ltd. / cleared 2010-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)