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Izi Medical Products, LLC · Model SF5003 · UDI-DI 00815212021749
1
510(k) clearances
142
Adverse events
13
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-10-10 | Siemens Medical Solutions USA, Inc | Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by |
| 2013-12-11 | Siemens Medical Solutions USA, Inc | In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality. |
| 2012-05-24 | GE Healthcare, LLC | It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exa |
| 2009-02-02 | GE Medical Systems, LLC | It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam |
| 2008-11-06 | Siemens Medical Solutions USA, Inc | Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury. |
| 2008-03-10 | Siemens Medical Solutions USA, Inc | The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially |
| 2008-01-03 | Varian Medical Systems Oncology Systems | Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images a |
| 2007-06-25 | Varian Medical Systems Inc | Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the ad |
| 2007-02-27 | Siemens Medical Solutions USA, Inc | Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient. |
| 2007-02-27 | Siemens Medical Solutions USA, Inc | Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient. |
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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.