Food, drugs, devices › NeuroLogica Corporation
Device recall: Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
FDA enforcement event 72171 is a device recall by NeuroLogica Corporation of Danvers, MA, initiated 14 Sep 2015 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 19 Jan 2017. 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 the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted."
Distribution
"Distributed to the states of NC, OH, MA, and MO."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0263-2016 | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. | 7 devices | Class II | Terminated | 18 Nov 2015 |
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 the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted."
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: "Distributed to the states of NC, OH, MA, and MO."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Jan 2017. "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.