FDA (Devices) recall action 83179
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
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.
Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.
Ad-Tech Medical Instrument Corporation is recalling depth electrodes because supplemental information incorrectly stated they were approved for use in the MR environment.
Ad-Tech Medical Instrument Corporation is recalling subdural electrodes because supplemental information incorrectly stated they were approved for use in MRI environments.