Yian Medical Technology (Haining) Co., Ltd.
Yian Medical Technology (Haining) Co., Ltd. · Model Heart3R-110 · UDI-DI 06975023416012
Description
The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The system is subject to the following limitations of use when stand-mounted: - The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. -The device may be used for imaging of the chest when used without a grid. This device is not intended for mammography.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 pawl may not have been |
| 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 pawl may not have been |
| 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 pawl may not have been |
| 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 in the manual, clea |
| 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 in the manual, clea |
| 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 in the manual, clea |
| 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 in the manual, clea |
| 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 in the manual, clea |
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