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AcuityPDR
RADMEDIX, LLC · Model Standard · UDI-DI 00810035220195
1
510(k) clearances
922
Adverse events (8 deaths)
170
Recalls
78
Facilities
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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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.