Recall Z-2715-2024
NeuroLogica Corporation · initiated July 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GM60A. Digital Diagnostic Mobile X-Ray System.
Codes / lots: 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.
Reason for recall
Potential for the anti-fall system of the device arm to fail.
FDA-determined cause: Device Design
Action taken
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 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.
Details
- Recall number
- Z-2715-2024
- Initiated
- July 8, 2024
- Posted by FDA
- August 22, 2024
- Product code
- IZL – System, X-Ray, Mobile
- Quantity
- 31 units
- 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.
- Recalling firm
- NeuroLogica Corporation, Danvers, MA