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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Lighting and Panel Monitor Arms

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 Class 2 Recall
Surgical Lighting and Panel Monitor Arms
see related information
Date Posted December 10, 2010
Recall Status1 Terminated on July 06, 2012
Recall Number Z-0591-2011
Recall Event ID 57216
Premarket Notification
510(K) Number
K922836 
Product Classification Lamp, Surgical - Product Code FTD
Product CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
Code Information 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.
Recalling Firm/
Manufacturer
Berchtold Corp.
1950 Hanahan Rd
N Charleston, South Carolina 29406-4878
For Additional Information Contact Chris Mannarino
843-569-6100 Ext. 322
Manufacturer Reason
for Recall
A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 7031 arms
Distribution Worldwide Distribution: Throught the U.S,.and the countries of Canada and Germany
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = BERCHTOLD HOLDING GMBH
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