NeuroLogica Corporation: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

Hazard

Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.

Details from the source

Reason for recall: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. Distribution: US Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WI & WV. Quantity: 261 devices Lot/code info: UDI-DI: 08806088582412, serial numbers: 5143M3HK400010M, 5143M3IJ800012D, 5143M3IK400005T, 5149M3IK400001H, 5149M3IK400002K, 5143M3IK400003Z, 5143M3GK500001H, 513YM3IK100001A, 5143M3HJ500001Y, 5143M3IJ600014H, 5143M3HK400002V, 5143M3JK400005Y, 5143M3HJ900001L, 5143M3IJ400007P, 5143M3HK400007T, 5143M3HK400003P, 513YM3IJA00001X, 5143M3JJ400007E, 5143M3IJ400006V, 5143M3JJ400006K, 5143M3JK400009V, 5143M3IJ200001D, 5143M3JJC00004Y, 5143M3JJ200017Y, 5143M3IHC00009M, 5143M3IJ100011V, 5143M3JJ300001K, 5143M3HJ600003K, 5143M3IK300002J, 5143M3JJ300003J, 5143M3JJ300002X, 5143M3JK400011A, 5143M3HK300016Y, 5143M3IJ800008L, 5143M3IJ600013B, 5143M3IJ100010M, 5143M3IJ100002P, 5143M3HK300011R, 5143M3HK200004H, 5143M3HK200006K, 5143M3JJC00001X, 5143M3IJ100009B, 5143M3IJ100006J, 5143M3HK300017E, 5143M3JK400006R, 5143M3JK400007B, 5143M3JK400004M, 5143M3HK300004E, 5143M3IJ600011M, 5143M3JK100012J, 514GM3HK100005L, 5143M3JK100003Z, 5143M3JK100002B, 5143M3IJC00001Y, 5143M3IK400002J, 5143M3IK400001P, 5143M3HK300007N, 514GM3HK100002R, 5143M3HK300010P, 5143M3HJA00002K, 514GM3IK400001L, 5143M3JJ200011L, 5143M3JJ300012N, 5143M3RJ100001M, 5143M3IJ600007N, 5143M3IHC00015L, 5143M3IHC00013X, 5143M3IHC00004N, 5143M3IHC00003Y, 5143M3JK400008N, 5143M3JK100015B, 5143M3HJA00006P, 5143M3HJ900007R, 5143M3JJ200012Z, 5143M3IK400008A, 5143M3JK400013K, 5143M3JJ700004K, 5143M3IHC00012Z, 5143M3JJ700001V, 514GM3JK300001A, 5143M3IK300008R, 5143M3IJ100001Y, 5143M3IHC00019T, 5143M3HK300001F, 5143M3HJA00010W, 5143M3IHC00018J

UPC codes

08806088582412

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.