Remote Diagnostic Technologies Ltd.

6 FDA enforcement actions

6 Total Recalls

0 Class I

5 Class II

1 Class III

Firm Details

Product Types: device
States: N/A

All Recalls

Class II: Risk 11/26/2025 device

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
Class II: Risk 05/30/2025 device

Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Class II: Risk 04/16/2025 device

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Class II: Risk 04/15/2025 device

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
Class III: Low Risk 10/28/2024 device

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Class II: Risk 05/09/2024 device

Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.