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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 581–600 of 1,000 recalls

Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Wright Medical Technology Inc

The package contents and package labeling do not match.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Sector USB"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Console"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S3ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A3ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S1ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class IITerminated

GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

GE Healthcare, LLC

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

November 4, 2021 · DeviceView details →
Class IITerminated

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

The kit contains a non-sterile needle.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator,980X1ENAIQC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
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