Mobius Imaging, LLC

Complete recall history across all FDA and CPSC categories, 7 total recalls

Mobius Imaging, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (7)

FDA medical device enforcement actions by Mobius Imaging, LLC

Date Product Reason Class
Dec 4, 2025 Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Posit... Class II
Dec 4, 2025 Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Posit... Class II
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred w... Class II
Nov 18, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received a report of a battery fire involving an Airo TruCT unit prev... Class II
Aug 1, 2018 AIRO Mobile CT System Model # MobiCT-32 The Tube Current Modulation feature (Modulated Scans) is not working in AIRO ... Class II
Sep 26, 2017 AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ i... If the tilt-drive motor has an intermittent connection or broken encoder or s... Class II
Dec 8, 2014 Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomograph... There is a risk that during the transfer of an image and navigation data to t... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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