Food, drugs, devices › NeuroLogica Corporation
Device recall: Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anat
NeuroLogica Corporation (Danvers, MA) initiated this device recall on 24 May 2017; FDA lists 1 product record under event 77384, classified Class II.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 9 Jul 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
"When performing the Stitching function on GU60A system, unintended area is exposed to radiation"
Distribution
"Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3036-2017 | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications | 87 units | Class II | Terminated | 6 Sep 2017 |
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: "When performing the Stitching function on GU60A system, unintended area is exposed to radiation"
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: "Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Jul 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.