CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
GM60A. Digital Diagnostic Mobile X-Ray System recalled by NeuroLogica
NeuroLogica is recalling GM60A. Digital Diagnostic Mobile X-Ray System, distributed nationwide in the US. The recall was initiated on 8 Jul 2024 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-2715-2024
- FDA event ID
- 95100
- Recalling firm
- NeuroLogica, Danvers, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jul 2024
- FDA classified
- 22 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Jul 2024 | Recall initiated by company | |
| 22 Aug 2024 | Classified by FDA | +45 days |
| 28 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the anti-fall system of the device arm to fail.
Product as listed by the FDA
GM60A. Digital Diagnostic Mobile X-Ray System.
Where it was distributed
US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.
Nationwide ArkansasConnecticutDistrict of ColumbiaGeorgiaIndianaKansasMassachusettsMarylandMissouriMississippiNorth CarolinaNorth DakotaNew JerseyNevadaOhioPennsylvaniaVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Potential for the anti-fall system of the device arm to fail.
Which lots are affected?
UDI: 08806088511153/ 08806088088266; Serial No. G69812, G69821, G69824, G69986, G69987, G71422, G71425, G71431, G71434, G71795, G71798, G71802, G72052, G72053, G72264, G72279, G72296, G72301, G72310, G72313, G72319, G72320, G72481, G72484, G72595, G72601, G72853, G72875, G73179, G73184, G73542; Samsung Serial No. 50WFM9BG900003M, 50WFM9BG900004J, 50WFM9BG900005H, 50WFM9BGA00001T, 50WFM9BGA00002B, 50WFM9BH300001E, 50WFM9BH300002W, 50WFM9BH300003Z, 50WFM9BH300004N, 50WFM9BH400001X, 50WFM9BH400002W, 50WFM9BH400003A, 50WFM9BH500001H, 50WFM9BH500002Y, 50WFM9BH600001P, 50WFM9BH600002L, 50WFM9BH600003F, 50WFM9BH600004Y, 50WFM9BH600005W, 50WFM9BH600006N, 50WFM9BH600007K, 50WFM9BH600008J, 50WFM9BH700002B, 50WFM9BH700001P, 50WFM9BH700003M, 50WFM9BH700004E, 50WFM9BH800002E, 50WFM9BH800003D, 50WFM9BH900001X, 50WFM9BH900002D, 50WFM9BHB00001T.
Where was it sold?
US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.
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 | 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 |
| Device | CLASS II | OmniTom Computed tomography x-ray system recalled by NeuroLogica | NeuroLogica | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
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|---|---|---|---|---|---|
| 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 |