Z-2175-2025Class II

Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The...

Name: Z-2175-2025 Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2025-05-30
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2025-05-30 / Open, Classified / root cause: software

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF... on 2025-05-30. FDA classified it as Class II and gives the reason as "Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2175-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-30
Posted: 2025-07-25
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.
Root cause tag: software
FDA root cause: Software change control
Action: On 5/30/3035, Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video Laryngoscope). Customers were asked to do the following: 1) Dispose of USB Flash Drive. 2) Ensure monitor is on Software version vx.34 or higher. 4) If your device(s) is on a software version below vx.34, contact firm representative for software update instructions. 5) Complete and return response form via email to [email protected] In addition, distributors were asked to do the following: 1) Modify the correction response form and substitute your firm's email and fax information. Send a copy of the correction notice and modified response form to each customer to whom you distribute the affected product. If you need any further information or support contact firm at (800) 722-9377 or email [email protected]
Quantity in commerce: 55
Distribution: Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
Product codes and lots: REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2175-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2175-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-25

Product code MHX

K201746Class IITempus Pro Patient MonitorRemote Diagnostic Technologies Limited / cleared 2020-09-18

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)