Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Inseego USB8 4G Dongle Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Inseego USB8 4G Dongle Kitsee related information
Date Initiated by FirmMay 30, 2025
Date PostedJuly 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2175-2025
Recall Event ID 97197
510(K)NumberK201746 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductInseego 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
Code Information REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28
FEI Number 3003832357
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
For Additional Information ContactPhilips Customer Services
800-7229377
Manufacturer 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for Recall		Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.
FDA Determined
Cause 2		Software change control
ActionOn 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Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video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 in Commerce55
DistributionWorldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
-
-