Samsung HME America, Inc.
Danvers, MA, US
Samsung HME America, Inc. appears in FDA device records in Danvers, MA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Samsung HME America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Neurologica Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Samsung HME America, Inc. between 2005 and 2025. The busiest year on record is 2005, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250928 | OmniTom Elite with PCD | JAK | Substantially Equivalent | |
| K233767 | OmniTom Elite | JAK | Substantially Equivalent | |
| K213649 | BodyTom 64 | JAK | Substantially Equivalent | |
| K171183 | OmniTom | JAK | Substantially Equivalent | |
| K142697 | NExCT 7 | JAK | Substantially Equivalent | |
| K102677 | BODYTOM NL 4000 | JAK | Substantially Equivalent | |
| K090811 | INSPIRA HD, MODEL: NL1000 | KPS | Substantially Equivalent | |
| K051765 | CERETOM, MODEL NL3000 | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004938766 | 3004938766 | Samsung HME America, Inc. | 14 Electronics Ave, Danvers, MA 01923 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0480-2026 | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. | Class II | Open, Classified | |
| Z-2715-2024 | GM60A. Digital Diagnostic Mobile X-Ray System. | Potential for the anti-fall system of the device arm to fail. | Class II | Open, Classified | |
| Z-1056-2024 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. | Class II | Open, Classified | |
| Z-2068-2023 | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000 | 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment | Class II | Open, Classified | |
| Z-1414-2023 | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System | Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm | Class II | Open, Classified | |
| Z-2772-2020 | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. | There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed. | Class II | Terminated | |
| Z-2276-2019 | WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09. | There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode. | Class II | Terminated | |
| Z-2275-2019 | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12 | There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode. | Class II | Terminated | |
| Z-1691-2019 | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications | Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks. | Class II | Terminated | |
| Z-1391-2018 | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical | While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit. | Class II | Terminated | |
| Z-0726-2018 | The GC80 Digital X-ray Imaging System | An image was obtained with over exposure during a Thorax examination using the AEC function. | Class II | Terminated | |
| Z-3036-2017 | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications | When performing the Stitching function on GU60A system, unintended area is exposed to radiation | Class II | Terminated | |
| Z-0263-2016 | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. | When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain