Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35

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…

Date

2024-12-04

Country

United States

Brand

Micro-X

Product

MICRO-X Rover Mobile X-ray System, # MXU-RV35

Classification

Class II

Units

US: TX, PR, MD, CA

Category

Drugs & medical

Source

FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

1. Check the product name, strength and lot number against the official notice.
2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Micro-X recalls

1. 2025-04-30
2. US
   Drugs & medicalClass II

   Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System…

   Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

   FDA · DeviceMicro-X Ltd.US: NJ, WA, Puerto Rico OUS: NoneOfficial notice →
3. 2025-04-23
4. US
   Drugs & medicalClass II

   Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System…

   Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

   FDA · DeviceMicro-X Ltd.US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US…Official notice →
5. 2024-12-18
6. US
   Drugs & medicalClass II

   Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV19

   During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a…

   FDA · DeviceMicro-X Ltd.US Nationwide Distribution: TX, CA, OH, ID, WA, AZOfficial notice →
7. US
   Drugs & medicalClass II

   Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

   Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

   FDA · DeviceMicro-X Ltd.US Nationwide Distribution: NJ, CA, PROfficial notice →
8. US
   Drugs & medicalClass II

   Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35

   Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

   FDA · DeviceMicro-X Ltd.Worldwide and US Nationwide Distribution: NJ, PR, CAOfficial notice →
9. 2022-10-05
10. US
    Drugs & medicalClass II

    Micro-X Ltd. recalls MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

    FDA · DeviceMicro-X Ltd.Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV,…Official notice →

Other drugs & medical recalls in the United States

1. 2024-12-11
2. US
   Drugs & medicalClass II

   American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use…

   Presence of Particulate Matter: Potential for glass delamination from the vials.

   FDA · DrugAmerican Regent, Inc.Nationwide in the USAOfficial notice →
3. US
   Drugs & medicalClass II

   Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only,…

   cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

   FDA · DrugAurobindo Pharma USA IncUSA NationwideOfficial notice →
4. US
   Drugs & medicalClass II

   ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC…

   Subpotent drug

   FDA · DrugACCORD HEALTHCARE, INC.USA NationwideOfficial notice →
5. 2024-12-04
6. US
   Drugs & medicalClass II

   Gauthier Biomedical, Inc. recalls TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)

   An out of specification component may result in the device exhibiting torque output higher than the design specification.

   FDA · DeviceGauthier Biomedical, Inc.US Nationwide distribution in the state of MA.Official notice →
7. US
   Drugs & medicalClass II

   LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

   Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to…

   FDA · DeviceLivaNova Deutschland GmbHUS Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.Official notice →
8. US
   Drugs & medicalClass II

   Securitas Healthcare LLC recalls Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver…

   Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

   FDA · DeviceSecuritas Healthcare LLCWorldwide distribution - US Nationwide and the countries of Canada, Switzerland.Official notice →