Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 19, 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 may loosen or fracture due to metal fatigue.
NeuroLogica Corporation recalled GM85 Digital Mobile X-ray imaging System; Model Number: GM85; — a moderate-severity action.
GM85 Digital Mobile X-ray imaging System; Model Number: GM85; was recalled by NeuroLogica Corporation in November 19, 2025. Reason: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to meta…. Check the official notice for the remedy. Verify recall #Z-0480-2026 with the FDA Devices before acting.
The recall
NeuroLogica Corporation issued this moderate-severity FDA Devices recall — The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to meta….
- Moderate
- severity level
- 236 units
- affected scope
- Class II
- classification
- November 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0480-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0480-2026) was formally reported on November 19, 2025, with the manufacturer initiating the action on October 7, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. NeuroLogica Corporation is listed as the recalling firm, operating out of Danvers, MA. Federal records list the affected scope as 236 units.
The documented reason for this recall is: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. Distribution data in the federal record shows the product reached: Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
236 units
Related Recalls
6
6 from same agency
Product description
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Reason for recall
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0480-2026 |
| Date reported | November 19, 2025 |
| Date initiated | October 7, 2025 |
| Recalling firm | NeuroLogica Corporation |
| Firm location | Danvers, MA |
| Affected scope | 236 units |
| Distribution | Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Ze… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0480-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;. Recalled by NeuroLogica Corporation. Units affected: 236 units.
Why was this product recalled? ▼
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0480-2026.
Where was the recalled product distributed? ▼
Distribution: Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab Emir., Vietnam,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0480-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 19, 2025.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.