Remote Diagnostic Technologies Ltd.: Device Recall

Recall Details

Recall Number

Z-2028-2024

Classification

Class II

Product Type

Device

Recalling Firm

Remote Diagnostic Technologies Ltd.

Status

Ongoing

Date Initiated

05/09/2024

Location

Farnborough, N/A, United Kingdom

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1745

Reason for Recall

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.

Product Description

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

Distribution Pattern

US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.

Other Recalls by Remote Diagnostic Technologies Ltd.

• Class II: Risk 11/26/2025
  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
  Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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
  software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
• Class II: Risk 04/15/2025
  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
  Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

View all recalls by Remote Diagnostic Technologies Ltd. →