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U.S. Department of Health and Human Services

Class 2 Device Recall GM60A

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 Class 2 Device Recall GM60Asee related information
Date Initiated by FirmJuly 08, 2024
Date PostedAugust 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2715-2024
Recall Event ID 95100
510(K)NumberK150097 
Product Classification System, x-ray, mobile - Product Code IZL
ProductGM60A. Digital Diagnostic Mobile X-Ray System.
Code Information 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.
FEI Number 3004938766
Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
For Additional Information ContactNinad Gujar
978-564-8632
Manufacturer Reason
for Recall		Potential for the anti-fall system of the device arm to fail.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 fcsa@neurologica.com 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.
Quantity in Commerce31 units
DistributionUS Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZL
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