NeuroLogica Corporation
Complete recall history across all FDA and CPSC categories — 13 total recalls
NeuroLogica Corporation 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 (13)
FDA medical device enforcement actions by NeuroLogica Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 7, 2025 | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm ma... | Class II |
| Jul 8, 2024 | GM60A. Digital Diagnostic Mobile X-Ray System. | Potential for the anti-fall system of the device arm to fail. | Class II |
| Dec 28, 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potent... | Class II |
| Jun 6, 2023 | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... | 1. Wheels loosening over time with use of the device could lead to the inabil... | Class II |
| Mar 8, 2023 | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray S... | Issue related to the operation of the arm latch within the column that suppor... | Class II |
| Jul 15, 2020 | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi... | There are potential issues related to the operational state of the scanner, s... | Class II |
| Jul 25, 2019 | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03... | There is a potential for probes overheating when decreasing the Doppler SV (S... | Class II |
| Jul 25, 2019 | WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19... | There is a potential for probes overheating when decreasing the Doppler SV (S... | Class II |
| May 6, 2019 | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85... | Potential issue related to the operation of the safety latch within the colum... | Class II |
| Jan 12, 2018 | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray i... | While transporting the portable machine with the retrofit equipment in a back... | Class II |
| Jun 22, 2017 | The GC80 Digital X-ray Imaging System | An image was obtained with over exposure during a Thorax examination using th... | Class II |
| May 24, 2017 | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in ... | When performing the Stitching function on GU60A system, unintended area is ex... | Class II |
| Sep 14, 2015 | Samsung GM60A-40S Intended for use in generating radiographic images of hu... | When the system is driving over a non-conductive floor and then over a conduc... | 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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