FDA Medical Device Recalls (openFDA)
NeuroLogica Corporation: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
- Recall number
- Z-1056-2024
- Recalling firm
- NeuroLogica Corporation
- Product
- Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
- Status
- Open, Classified
- Initiated
- 2023-12-28
- Posted
- 2024-02-09
- Terminated
- not on file
- Reason
- Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- Root cause
- Process design
- Action
- An "Urgent - Medical Device Correction" notice was issued via email on December 28, 2023, cosigned by representatives of Samsung Electronics Co., Ltd. and NeuroLogica Corp. The notice describes the product, problem and actions to taken. The customers were instructed to continue to use the GM85 systems and Service Engineers will contact you to arrange for on-site correction. Share this notice with users within your organization or anywhere the devices may have been transferred. Customer Reply Form are to be completed and returned via email to fsca@neurologica.com. Contact your local representative with questions email: SupportBI@bostonimaging.com, 1-800-976-0980.
- Quantity
- 261 devices
- 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.
- Lot, serial or model codes
- 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, 513YM3IK400001W, 5143M3IJ100003X, 5143M3HK400009W, 5143M3JJ500002M, 5143M3IHC00008E, 5143M3HK300019Z, 5143M3JJ200016T, 5143M3JK400010W, 5143M3IJ800013Y, 5143M3JK500001M, 5143M3JK500006X, 5143M3JK100006N, 5143M3IJ300004W, 5143M3JJ200014F, 5143M3HJ900003W, 5143M3HJ900002V, 5143M3IJ400003R, 5143M3IJ400004B, 5143M3JJ200005X, 5143M3JJ200004Y, 5143M3RJ100002V, 5143M3IHC00014H, 5143M3IJ600008K, 5143M3IJ200002F, 5143M3JJ200007W, 5143M3HJ900006H, 5143M3JJ300011Z, 5143M3JJ200002M, 5143M3JJ200001F, 5143M3HJA00005A, 5143M3HJA00004Y, 5143M3GK500002Y, 5143M3HJA00007D, 5143M3HJ900004M, 5143M3HJ900005J, 5143M3IJ600006W, 5143M3HJ500005P, 5143M3HJ500006W, 5143M3JJ400002X, 5143M3DHB00001M, 5143M3HK300018W, 514GM3HK100001E, 5143M3JJ700003D, 5143M3JJ700002R, 5143M3JK100014L, 5143M3HK300006Z, 5143M3IJ800001B, 5143M3IJ800003J, 5143M3IJ800002V, 5143M3IJ800005X, 5143M3IJ800004F, 5143M3JJ700005W, 5143M3IHC00005J, 5143M3JK500007L, 5143M3JK500002P, 5143M3JK500005V, 5143M3JK500003W, 5143M3IK400009H, 5143M3HJ600005D, 513YM3IK500003Z, 5143M3IK400007W, 513YM3IK500001K, 513YM3IK500004H, 5143M3IJ100012T, 5143M3HJ500004M, 5143M3IJ600004F, 5143M3IJ800011E, 5143M3IJ600005Y, 5149M3IK400003E, 5143M3IJ800007K, 5143M3IJ500001B, 5143M3IJ100004E, 5143M3HJ900009E, 5143M3IJ800014B, 5143M3IHC00002L, 5143M3IK300001X, 5143M3HK300003Y, 5143M3JK100008H, 5143M3JJ200015M, 5143M3JK400003D, 5143M3IK400006X, 5143M3IJ100005R, 5143M3IJ600001H, 5143M3JJ200018X, 5143M3HJA00008X, 5143M3JK100007F, 5143M3IJ800009M, 5143M3IJ400005N, 5143M3IJ200003M, 513YM3IK500005Y, 513YM3IK100002D, 513YM3IK400002A, 513YM3IK100003N, 5143M3IK300006T, 5143M3HK400004J, 5143M3IJB00003H, 5143M3IHC00001H, 5143M3JJ200009A, 5143M3HK200005V, 5143M3GK500003J, 5143M3IJ300002Y, 5143M3IJ300006N, 5143M3HJ900008F, 5143M3IHC00011V, 5143M3JJ400005H, 5143M3RJ100003T, 5143M3HJ900010Z, 5143M3JJC00002H, 5143M3HK300012L, 5143M3JJ200008B, 5143M3JJ400001T, 5143M3IHC00006T, 514GM3JJ900001R, 5143M3IJ600003L, 5143M3JJ200010J, 5143M3HJ500003A, 5143M3IJ600002P, 5143M3HJ500002J, 5143M3HJA00003Z, 5143M3IK300009L, 5143M3IJC00002N, 5143M3IK400010R, 5143M3IJ300003E, 5143M3HJA00001B, 5143M3HK400008X, 5143M3JK400012H, 5143M3HK300013A, 5143M3JK100001L, 5143M3IJ600012X, 513YM3IK500002R, 5143M3HK400006F, 5143M3JK400014E, 5143M3JJ300007T, 5143M3JJ300006H, 5143M3IK400004F, 5143M3JK100004A, 514GM3HK100003J, 5143M3JJC00003L, 5143M3JJB00001F, 5143M3HJA00009N, 5143M3IJ600010Z, 5143M3JK100013W, 5143M3IK500001F, 5143M3JJ300008P, 5143M3IHC00017N, 5143M3IHC00016Y, 5143M3JK500004D, 5143M3IJ600009J, 5143M3IJ100013K, 5143M3IK300005H, 5143M3IK300007P, 5143M3HK300009K, 5143M3JK100009M, 5143M3JJ300010W, 5143M3GK500006P, 5143M3JK100010E, 5143M3JK100011R, 5143M3JK100005D, 5143M3IHC00010R, 5143M3JJC00006J, 5143M3JJC00005N, 5143M3JJ300009R, 5143M3HK400005Z, 514GM3HK100004W, 5143M3HK300008M, 5143M3HK300005W, 5143M3JJ300004B, 5143M3JJ300005D, 5143M3JJ200006R, 5143M3IJ300005Z, 5143M3IHC00007A, 5143M3IJ600015P, 5143M3JJ200013D, 5143M3HK300002V, 5143M3HJ600004J.
- 510(k) numbers
- ["K222353"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3004938766
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28