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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.