Events

Recall of Device Recall Chromovision High Definition (HD) Wireless Camera

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Berchtold Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62683
  • Event Risk Class
    Class 3
  • Event Number
    Z-2148-2012
  • Event Initiated Date
    2012-07-10
  • Event Date Posted
    2012-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111349
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, cine, surgical, without audio - Product Code FWH
  • Reason
    Defective camera: there is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss.
  • Action
    BERCHTOLD Corporation sent a letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. BERCHTOLD will replace the customer's cameras at no cost to the customer. Customers with questions should call 843-569-6100, ext 322. For questions regarding this recall call 843-569-6100.

Device

Device Recall Chromovision High Definition (HD) Wireless Camera
  • Model / Serial
    Serial numbers: 350111-S10017, 350111-S10018, 350111-S10019, 350111-S10020, 350111-S10021, 350111-S10022, 350111-S10023, 350111-S10024, 350111-S10025, 350111-S10026, 350111-S10027, 350111-S10028, 350111-S10030, 350111-S10031, 350111-S10032, 350111-S10033, 350111-S10034, 350111-S10035, 350111-S10036, 350111-S10037, 350111-S10038, 350111-S10039, 350111-S10040, 350111-S10041, 350111-S10043, 350111-S10044, 350111-S10045, 350111-S10046, 350111-S10047, 350111-S10048, 350111-S10049, 350111-S10050, 350111-S10051, 350111-S10052, 350111-S10053, 350111-S10054, 350111-S10055, 350111-S10056, 350111-S10060, 350111-S10061, 350111-S10062, 350111-S10063, 350111-S10064, 350111-S10065, 350111-S10066, 350111-S10067, 350111-S10068, 350111-S10069, 350111-S10070, 350111-S10071, 350111-S10072, 350111-S10073, 350111-S10074, 350111-S10075, 350111-S10076, 350111-S10077, 350111-S10078, 350111-S10079, 350111-S10080, 350111-S10081, 350111-S10082, 350111-S10083, 350111-S10084, 350111-S10085, 350111-S10086, 350111-S10087, 350111-S10088, 350111-S10089, 350111-S10090, 350111-S10091, 350111-S10092, 350111-S10093, 350111-S10094, 350111-S10095, 350111-S10096, 350111-S10097, 350111-S10098, 350111-S10099, 350111-S10100, 350111-S10101, 350111-S10102, 350111-S10103, 350111-S10104, 350111-S10105, 350111-S10106, 350111-S10107, 350111-S10108, 350111-S10109, 350111-S10110, 350111-S10111, 350111-S10112, 350111-S10113, 350111-S10114, 350111-S10115, 350111-S10116, 350111-S10117, 350111-S10118, 350111-S10119, 350111-S10120, 350111-S10121, 350111-S10122, 350111-S10123, 350111-S10124, 350111-S10125, 350111-S10126, 350111-S10127, 350111-S10128, 350111-S10129, 350111-S10130, 350111-S10131, 350111-S10132, 350111-S10133, 350111-S10134, 350111-S10135, 350111-S10136, 350111-S10137, 350111-S10138, 350111-S10139, 350111-S10140, 350111-S10141, 350111-S10142, 350111-S10143, 350111-S10144, 350111-S10145, 350111-S10146, 350111-S10147, 350111-S10148, 350111-S10149, 350111-S10150, 350111-S10151, 350111-S10152, 350111-S10153, 350111-S10154, 350111-S10155, 350111-S10156, 350111-S10157, 350111-S10158, 350111-S10159, 350111-S10160, 350111-S10161, 350111-S10162, 350111-S10164, 350111-S10165, 350111-S10166, 350111-S10167, 350111-S10168, 350111-S10169, 350111-S10170, 350111-S10171, 350111-S10172, 350111-S10173, 350111-S10176, 350111-S10177, 350111-S10178, 350111-S10179, 350111-S10180, 350111-S10181, 350111-S10192, 350111-S10193, 350111-S10194, 350111-S10195, 350111-S10196, 350111-S10197, 350111-S10198, 350111-S10199, 350111-S10200, 350111-S10201, 350111-S10202, 350111-S10203, 350111-S10204, 350111-S10205, 350111-S10206, 350111-S10207, 350111-S10208, 350111-S10209, 350111-S10210, 350111-S10211, 350111-S10212, 350111-S10213, 350111-S10215, 350111-S10216, 350111-S10218, 350111-S10219, 350111-S10220, 350111-S10221, 350111-S10222, 350111-S10223, 350111-S10224, 350111-S10225, 350111-S10226, 350111-S10227, 350111-S10228, 350111-S10229, 350111-S10230, 350111-S10231, 350111-S10232, 350111-S10233, 350111-S10234, 350111-S10235, 350111-S10236, 350111-S10237, 350111-S10238, 350111-S10239, 350111-S10248, 350111-S10249, 350111-S10250, 350111-S10251, 350111-S10252, 350111-S10253, 350111-S10254, 350111-S10255, 350111-S10256, 350111-S10257, 350111-S10258, 350111-S10259, 350111-S10260, 350111-S10261, 350111-S10262, 350111-S10263, 350111-S10265, 350111-S10266, 350111-S10267, 350111-S10268, 350111-S10269, 350111-S10270, 350111-S10273, 350111-S10274, 350111-S10276, 350111-S10277, 350111-S10278, 350111-S10279, 350111-S10280, 350111-S10281, 350111-S10282, 350111-S10283, 350111-S10284, 350111-S10285, 350111-S10286, 350111-S10287, 350111-S10288, 350111-S10289, 350111-S10290, 350111-S10291, 350111-S10292, 350111-S10293, 350111-S10295, 350111-S10296, 350111-S10297, 350111-S10298, 350111-S10300, 350111-S10301, 350111-S10302, 350111-S10303, 350111-S10305, 350111-S10306, 350111-S10307, 350111-S10309 and 350111-S10310.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, MI, MS, and NH.
  • Product Description
    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. || Visual recording of surgical procedures.
  • Manufacturer
    Berchtold Corp.

Manufacturer

Berchtold Corp.
  • Manufacturer Address
    Berchtold Corp., 1950 Hanahan Rd, N Charleston SC 29406-4878
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA