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IA-12LT
SHIMADZU CORPORATION · Model 532-16882-01 · UDI-DI 04540217031887
1
510(k) clearances
90,606
Adverse events (20 deaths)
223
Recalls
135
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-27 | Philips North America | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to mee |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea |
| 2024-07-29 | Agfa N.V. | Potential for the front lever chain of the DR 800 table to fail. |
| 2023-12-15 | Philips North America | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patien |
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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.