GM60A. Digital Diagnostic Mobile X-Ray System recallZ-2715-2024 · NeuroLogica Corporation · initiated Jul 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NeuroLogica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the anti-fall system of the device arm to fail.
FDA root cause category: Device Design
What the company is doing
Consignees were emailed an "Urgent -- Medical Device Correction; GM60A Digital X-ray Imaging System" notification the week of 7/8/2024. The notification instructs consignees to share the recall notification with those in their organization that utilize the affected devices and forward the notification if devices have been transferred. Affected systems may continue to be used. Consignees are to check on-hand devices to confirm if they are affected by the field action and return the response form back indicating any devices that require correction by email to [email protected] within 10 business days. Samsung Electronics will send service engineers to affected consignees to correct devices free of charge. Service will be coordinated by Samsung Electronics and should be completed by October 2024. Consignees with any questions are to contact their local Samsung Electronics representative.
Recall details
- Recall number
- Z-2715-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2024
- Posted by the FDA
- Aug 22, 2024
- Recalling firm
- NeuroLogica Corporation
- Quantity
- 31 units
- Product code
- IZL
- FDA submissions
- K150097
- Distribution
- 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.
Product description
GM60A. Digital Diagnostic Mobile X-Ray System.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NA GM60A-40SSamsung Electronics Co., Ltd. · System, X-Ray, Mobile1 recall0 reports
- NA GM60A-32SSamsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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