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LODOX
LODOX SYSTEMS (PTY) LTD · Model Xmplar-dr · UDI-DI 06009880828135
JAK
Prescription
1
510(k) clearances
5,267
Adverse events (219 deaths)
873
Recalls
164
Facilities
Description
The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | PHILIPS MEDICAL SYSTEMS | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. |
| 2026-08-18 | Philips North America Llc | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in t |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
| 2026-08-07 | Philips North America Llc | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.