The Recall Desk

FDA (Devices) recall action 86366

Carl Zeiss Meditec AG recalled 2 products on 2020-12-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-23
Critical
0
Units
735

Why these products were recalled

Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2020-12-23

    Carl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling 132 VISUREF 150 diagnostic instruments due to an incorrect component that may cause electrical shocks to users.

    Product
    Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2020-12-23

    Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.

    Product
    Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
    Category
    Distribution
    35 states