Events

Recall of Device Recall Surgical Lighting and Panel Monitor Arms

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
    57216
  • Event Risk Class
    Class 2
  • Event Number
    Z-0591-2011
  • Event Initiated Date
    2009-11-16
  • Event Date Posted
    2010-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95615
  • 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
    Lamp, surgical - Product Code FTD
  • Reason
    A mechanical failure of a welded joint within the spring arm may result in the rapid drop of a monitor to the mechanical stop.
  • Action
    Berchtold issued a Product Safety Notification letter on November 16, 2009 identifying the affected device and issue prompting the action. Consignees were instructed to: Exercise caution when adjusting the position of the surgical lights or flat panel monitors. While an event is highly unlikely, the likelihood does increase when the spring arm is being repositioned. Identify a specific contact person for their facility to facilitate the communication and field action process with BERCHTOLD. The following action is being planned: To further identify if their units are part of the affected population, determine the supplier serial number identification and specific location for each spring arm in their facility. Report the facility information, supplier spring arm serial numbers and specific location or spring arms to a BERCHTOLD. Detail instructions on serial number identification and the method of reporting to BERCHTOLD will also be provided in a subsequent communication. Once BERCHTOLD has received the serial numbers of their spring arm assembly, customers will be notified whether their particular units are affected and the further required action. Berchtold Corporation can be contacted at 1 800 968 6097 about this action.

Device

Device Recall Surgical Lighting and Panel Monitor Arms
  • Model / Serial
    Spring Arm Serial Numbers: 010103837915-38114, 010101835874-35973, 010101836138, 010103837680-37779, 010101836309-36408, 10109841913-41942, 010107841041-41060, 010106840378-40407, 010104838741-38770, 010102837580-37609, 010102837341-37370, 01010183669, 010112735745-35804, 010112735193-35302, 010111734501-34663, 010103838406-38555, 010101835988-36137, 010103838574-38603, 010102837465-37494, 010102837301-37340, 010112735125-35134, 010109946662-46711, 010106945840-45866, 010110842349-42388, 010107841061-41100, 010107840798-40837, 010107840778-40797, 010103838286-38325, 010103838286-38325, 010102836829-36868, 010109946642-46661, 010107946042-46050, 010109842141-42180, 010109842140-42140, 010109841871-41910, 010108841499-41538, 010107840959-40998, 010106840715-40754, 010104839108-39147, 010105839565-39604, 010104839098-39107, 010104838907-38961, 010102837525-37578, 010102837579, 010101836778-36813, 010101835974-35977, 010204803835-03844, 010202802298-02307, 010202802223-02232, 010201801889-01898, 010201801569-01578, 010211807820-07969, 010211807720-07819, 010210807565-07614, 010210807454-07553, 010210807254-07453, 010209806644-06893, 010209806504-06603, 010208806352-06501, 010208806262-06311, 010208806092-06141, 010207805722-05771, 010207805479-05681, 010206805229-05328, 010206805079-05228, 010205804650-04749, 010205804358-04407, 010204803965-04164, 010204803965-04014, 010204803535-03634, 010202802579-02628, 010201802039-02088, 010201801839-01888, 010201801189-01338, 010205804500-04649, 010204804220-04269, 010205804408-04457, 010204804170-04219, 010204804065-04164, 010204803635-03734, 010203803485-03534, 010203803375-03424, 010203803275-03374, 010203802709-02808, 010202802308-02407, 010202802408-02507, 010201801899-01998, 010201801639-01738, 010201801739-01838, 010201801089-01188, 010212808270-08409, 010211808210-08269, 010209806994-07053, 010209806894-06993, 010209806604-06643, 010208806312-06351, 010208806202-06261, 010208806142-06201, 010207805979-06038, 010207805772-05871, 010204803865-03964, 010104803735-03834, 010203802909-03008, 010201802089-02188, 010201801999-02038, 010201801579-01638, 010207805892-05911, 010207805872-05891 and 010105839563-39564.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throught the U.S,.and the countries of Canada and Germany
  • Product Description
    CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
  • 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