Data Foundry

Medical device recalls 2012

Chromovision High Definition — Class III medical device recall Z-2148-2012

Terminated recall by Berchtold Corp., reported 2012-08-15, distributed nationwide. Defective camera: There is a possibility that the connection of the wires to the connector may become loose, c

Recall numberZ-2148-2012
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBerchtold Corp., N Charleston, SC, United States
Recall initiated2012-07-10
Classified2012-08-06
Reported by FDA2012-08-15
Terminated2013-06-06
DistributedNationwide (US)
Quantity17 cameras
Serial numbers350111-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 and 233 more

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.