Home › Device types › IZL
System, X-Ray, Mobile
FDA product code IZL · Class 2 · Radiology
309
Registered devices
929
Adverse events
171
Recalls
238
510(k) clearances
Devices with this code
STEPHANIX — STEPHANIXDRX-Revolution Mobile X-ray System — CARESTREAM HEALTH, INC.SEDECAL — SEDECALAcuityPDR — RADMEDIX, LLCSEDECAL — SEDECALFDR AQRO — FUJIFILM CORPORATIONSEDECAL — SEDECALAirRay — Poskom Co., Ltd.AcuityPDR — RADMEDIX, LLCSIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.DRGEM — DRGEM CorporationAcuityPDR — RADMEDIX, LLCDRGEM — DRGEM CorporationSEDECAL — SEDECALAcuityPDR — RADMEDIX, LLCMinXray — MINXRAY, INC.MinXray — MINXRAY, INC.Portable X-Ray System — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.NA — ECOTRONNA — Samsung Electronics Co., Ltd.NA — ECOTRONALPHA SOURCE BATTERY — ALPHA SOURCE INC.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-18 | Philips North America | Potential for the device to fail immediately after an exposure, causing the system to remain stationary. |
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-03-27 | Micro-X Ltd. | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| 2025-10-07 | NeuroLogica Corporation | 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. |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
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