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Sterimed
STERIMED LLC · Model RC0596 · UDI-DI 00850341007448
1
510(k) clearances
7,625
Adverse events (85 deaths)
259
Recalls
147
Facilities
Description
Remote Cover 5" X 96"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure a |
| 2021-12-16 | Shimadzu Medical Systems | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
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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.