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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 661–680 of 1,000 recalls

Class IITerminated

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Siemens Medical Solutions USA, Inc

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

August 30, 2021 · DeviceView details →
Class IITerminated

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Xstrahl Limited

Base plate may detach from the main body of the treatment applicator.

August 27, 2021 · DeviceView details →
Class IITerminated

10 ga ARS Decompression Needle, Part Number ZZ-0298

North American Rescue LLC.

The device includes the incorrect Instructions for Use.

August 27, 2021 · DeviceView details →
Class IITerminated

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

PTW NORTH AMERICA CORPORATION

When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results

August 27, 2021 · DeviceView details →
Class IITerminated

United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

Uoc Usa Inc

Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

August 27, 2021 · DeviceView details →
Class IITerminated

SIGNA Pioneer nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Optima MR450w 1.5T nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Architect nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Voyager nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Artist nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Discovery MR750 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

SIGNA Premier nuclear magnetic resonance imaging system

GE Healthcare, LLC

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

August 26, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Atrium Medical Corporation

The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

August 25, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

August 25, 2021 · DeviceView details →
Class IITerminated

HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm

Zhejiang Kindly Medical Devices Co., Ltd.

Potential for difficulty in safety mechanism activation.

August 24, 2021 · DeviceView details →
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