Z-0591-2011

CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms

Name: Z-0591-2011 CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms
Creator: Berchtold Corp.
Published: 2009-11-16
License: https://open.fda.gov/license/

Berchtold Corp. / initiated 2009-11-16 / Terminated / root cause: manufacturing process

FDA source

Berchtold Corp. began a recall of CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms on 2009-11-16. The reason FDA records is "A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0591-2011
Status: Terminated
Initiated: 2009-11-16
Posted: 2010-12-10
Terminated: 2012-07-06
Recalling firm: Berchtold Corp.
Product: CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
Product code: FTD Lamp, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Other
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
Product codes and lots: 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 code FTD

K922836Class IIChromophareBerchtold Holding GmbH / cleared 1992-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)