Food, drugs, devices › NeuroLogica Corporation
Device recall: Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
FDA enforcement event 79628 is a device recall by NeuroLogica Corporation of Danvers, MA, initiated 12 Jan 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 14 Aug 2018. Initiation: voluntary: firm initiated. NeuroLogica Corporation has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
NeuroLogica Corporation, Danvers, MA.
Reason for recall
"While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit."
Distribution
"US Distribution . Only one consignee was shipped 16 units of the affected device."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1391-2018 | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical | 16 units | Class II | Terminated | 25 Apr 2018 |
Context
Other enforcement events for NeuroLogica Corporation
All 12 events for NeuroLogica Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution . Only one consignee was shipped 16 units of the affected device."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Aug 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.