FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: 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
- Recall number
- Z-2175-2025
- 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
- Status
- Open, Classified
- Initiated
- 2025-05-30
- Posted
- 2025-07-25
- Terminated
- not on file
- Reason
- Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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
- 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Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video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 ECR.Recall.Response@Philips.com 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 ECR.Recall.Response@Philips.com
- Quantity
- 55
- Distribution
- Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
- Lot, serial or model codes
- REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28
- 510(k) numbers
- ["K201746"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3003832357
- Firm city
- Farnborough
- 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