Events

Field Safety Notices about Arctic Sun® Temperature Management System

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Medivance.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    310
  • Date
    2015-11-23
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Arctic Sun® Temperature Management System
  • Model / Serial
    Catalog Number: 5000-01-01, 5000-01-02, 5000-00-00 Serial Number: 1294 1295 1296 1297 1298 1299 1310 1311 1313 1335 1336 1337 1338 1339 1350 1351 1352 1353 1354 1365 1366 1367 1368 1369 1375 1376 1377 1378 1379 1425 1426 1427 1428 1429 1430 1431 1432 1433 1434 1463 1465 1466 1467 1468 1469 1470 1471 1472 1473 1474 1475 1476 1494 1527 1528 1529 1530 1531 1533 1534 1535 1548 1549 1550 1551 1553 1554 1555 1556 1558 1611 1612 1613 1616 1617 1618 1619 1620 1661 1665 1686 1687 1688 1689 1690 1691 1692 1692 1693 1694 1771 1772 1773 1774 1775 1776 1797 1798 1799 1800 1800 1801 1802 1803 1803 1804 1805 1806 1827 1828 1829 1910 1911 1912 1914 1916 1918 1919 1937 1939 1940 1976 1977 2054 2055 2056 2056 2057 2058 2059 2060 2061 2062 2064 2075 2076 2077 2078 2079 2080 2081 2082 2083 2085 2086 2087 2089 2090 2091 2092 2093 2094 2094 2094 2095 2096 2097 2100 2130 2137 2138 2139 2170 2171 2171 2172 2173 2174 2175 2176 2176 2177 2177 2205 2206 2206 2206 2207 2208 2209 2210 2211 2212 2214 2226 2227 2228 2230 2231 2232 2232 2282 2283 2284 2285 2286 2287 2301 2302 2303 2304 2354 2355 2356 2357 2358 2359 2360 2361 2362 2363 2364 2365 2366 2367 2378 2379 2381 2382 2382 2383 2384 2385 2386 2386 2387 2387 2388 2390 2391 2392 2393 2394 2430 2431 2432 2432 2433 2434 2435 2436 2437 2437 2438 2439 2440 2442 2443 2445 2446 2448 2449 2450 2461 2462 2464 2465 2466 2467 2472 2474 2502 2507 2511 2512 2512 2513 2513 2514 2516 2517 2518 2518 2519 2541 2542 2543 2544 2545 2546 2547 2548 2549 2549 2550 2551 2552 2552 2553 2554 2641 2642 2642 2644 2644 2645 2646 2646 2647 2648 2648 2651 2652 2663 2665 2667 2668 2671 2674 2675 2676 2676 2676 2677 2677 2678 2680 2681 2682 2683 2684 2684 2685 2686 2687 2713 2714 2715 2716 2716 2717 2718 2719 2720 2721 2743 2744 2756 2757 2757 2758 2761 2762 2762 2763 2764 2782 2783 2784 2786 2787 2787 2789 2790 2791 2807 2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2838 2839 2840 2841 2842 2843 2844 2844 2845 2846 2847 2863 2864 2865 2866 2867 2868 2869 2870 2871 2872 2873 2874 2875 2876 2877 2878 2879 2881 2882 2883 2887 2888 2936
  • Product Description
    Electromechanical medical devices
  • Manufacturer
    Medivance

Manufacturer

Medivance