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Ultreon™
ST. JUDE MEDICAL, INC. · Model 1015191 · UDI-DI 05415067045331
NQQ
Prescription
1
510(k) clearances
69
Adverse events
3
Recalls
26
Facilities
Description
1.0 Software Update vF.0.1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-11 | Ninepoint Medical Inc. | Distal tips of the probes may detach from the probe shaft during use. |
| 2011-12-22 | Imalux Corporation | During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit. |
| 2010-07-20 | Optovue Inc. | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of 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.