Z-2148-2012Class III

Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures

Name: Z-2148-2012 Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures
Creator: Berchtold Corp.
Published: 2012-07-10
License: https://open.fda.gov/license/

Berchtold Corp. / initiated 2012-07-10 / Terminated / root cause: manufacturing process

FDA source

Berchtold Corp. began a recall of Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures on 2012-07-10. FDA classified it as Class III and gives the reason as "Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss". 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-2148-2012
Classification: Class III
Status: Terminated
Initiated: 2012-07-10
Posted: 2012-08-06
Terminated: 2013-06-06
Recalling firm: Berchtold Corp.
Product: Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
Product code: FWH Camera, Cine, Surgical, Without Audio
Reason for recall: Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 17 cameras
Distribution: Nationwide Distribution including FL, MI, MS, and NH.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2148-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2148-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-06

Product code FWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)