FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: 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.
- Recall number
- Z-2183-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-03-25
- Posted
- 2011-05-11
- Terminated
- 2011-09-16
- Reason
- It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.
- 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
- 19 units
- Distribution
- Nationwide Distribution -- KY, MD, VA, and FL.
- Lot, serial or model codes
- Identification Numbers: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020.
- 510(k) numbers
- ["K101264"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 3003832357
- Firm city
- Basingstoke Hampshire
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28