CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Samsung GM60A-40S Intended for use recalled by NeuroLogica
NeuroLogica is recalling Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy, distributed in Massachusetts, Missouri, North Carolina, Ohio. The recall was initiated on 14 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0263-2016
- FDA event ID
- 72171
- Recalling firm
- NeuroLogica, Danvers, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Sep 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +57 days |
| 18 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Where it was distributed
Distributed to the states of NC, OH, MA, and MO.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
Where was it sold?
Distributed to the states of NC, OH, MA, and MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from NeuroLogica
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|---|---|---|---|---|---|
| Device | CLASS II | GM85 Digital Mobile X-ray imaging System recalled by NeuroLogica | NeuroLogica | Foreign Material | Nationwide |
| Device | CLASS II | GM60A. Digital Diagnostic Mobile X-Ray System recalled by NeuroLogica | NeuroLogica | Other | Nationwide |
| Device | CLASS II | Samsung Digital Diagnostic Mobile X-ray System recalled by NeuroLogica | NeuroLogica | Other | Nationwide |
| Device | CLASS II | OmniTom/OmniTom Elite- X-ray computed tomography recalled by NeuroLogica | NeuroLogica | Other | Nationwide |
| Device | CLASS II | Samsung GM85 Digital X-ray Imaging System-A Digital recalled | NeuroLogica | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |