Low FDA (Devices)·Z-2148-2012·Announced 2012-08-15

Berchtold Chromovision HD Wireless Camera Recall for Loose Wire Connections

Berchtold Corp. is recalling 17 Chromovision HD Wireless Cameras because loose wire connections may cause image distortion or loss during surgical procedures.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates the defect is not likely to cause adverse health consequences. The hazard is limited to image distortion or loss, which is a functional defect rather than a direct physical injury risk.

Plain-English summary

Berchtold Corp. is recalling 17 units of the Chromovision High Definition (HD) Wireless Camera, Part Number CC-9715900. The recall was initiated because there is a possibility that the connection of the wires to the connector may become loose. This defect can cause image distortion or loss of the visual recording during surgical procedures.

The affected cameras were distributed nationwide, including in Florida, Michigan, Mississippi, and New Hampshire. The specific serial numbers for the 17 recalled units are listed in the official FDA recall record Z-2148-2012.

Healthcare facilities and users should stop using the affected cameras and contact Berchtold Corp. for instructions on how to return or replace the devices. The FDA has classified this recall as Class III, indicating that the defect is not likely to cause adverse health consequences.

The recalled product

Product: Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
Manufacturer: Berchtold Corp.
Category: Medical Device — Surgical Imaging
Hazard: image-distortion
signal-loss
Affected units: 17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Berchtold Corp.

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