Recall Register

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NeuroLogica Corporation

FDA recalling firm · 12 enforcement events · 13 product records · 2015–2025 · MA

NeuroLogica Corporation has 12 FDA enforcement events on this register (13 product records) between 2015 and 2025: 12 device; the busiest year was 2023 with 3.

0% of its events are Class I; the most common class is Class II (12). 5 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 Oct 2025GM85 Digital Mobile X-ray imaging System; Model Number: GM85;DeviceClass II1Ongoing
8 Jul 2024GM60A. Digital Diagnostic Mobile X-Ray System.DeviceClass II1Ongoing
28 Dec 2023Samsung Digital Diagnostic Mobile X-ray System, Model GM85.DeviceClass II1Ongoing
6 Jun 2023OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000DeviceClass II1Ongoing
8 Mar 2023Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray SystemDeviceClass II1Ongoing
15 Jul 2020OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.DeviceClass II1Terminated
25 Jul 2019HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12DeviceClass II2Terminated
6 May 2019Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applicationsDeviceClass II1Terminated
12 Jan 2018Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) MedicalDeviceClass II1Terminated
22 Jun 2017The GC80 Digital X-ray Imaging SystemDeviceClass II1Terminated
24 May 2017Samsung 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 applicationsDeviceClass II1Terminated
14 Sep 2015Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.DeviceClass II1Terminated

By type and class

Device12
Class II12

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for NeuroLogica Corporation by year initiated.

Questions and answers

How many FDA recalls has NeuroLogica Corporation had?

12 enforcement events (13 product records) on this register, 2015–2025: 12 device.

Are any NeuroLogica Corporation recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are NeuroLogica Corporation recalls?

12 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.