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U.S. Department of Health and Human Services

Class 2 Device Recall MicroX Rover

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 Class 2 Device Recall MicroX Roversee related information
Date Initiated by FirmOctober 22, 2024
Date PostedNovember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0580-2025
Recall Event ID 95624
510(K)NumberK211423 
Product Classification System, x-ray, mobile - Product Code IZL
ProductMICRO-X Rover Mobile X-ray System, # MXU-RV35
Code Information UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
FEI Number 3012855798
Recalling Firm/
Manufacturer		 Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia
For Additional Information Contact
+61405298471
Manufacturer Reason
for Recall		Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
FDA Determined
Cause 2		Environmental control
ActionOn 10/22/24, Service Bulletin SB007-23-1.0 was emailed to customers restating receiving, storage, and operation conditions and informing customers that extreme humidity environments can adversely affect the equipment. For further information contact your local service representative: phone: 1-206-249-8764 Email: support-us@micro-x.com
Quantity in Commerce6
DistributionUS: TX, PR, MD, CA
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 = IZL
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