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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 561–580 of 1,000 recalls

Class IITerminated

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Medtronic Sofamor Danek USA Inc

Engraving on implants may not match what is listed on the pouch labels.

September 2, 2021 · DeviceView details →

Class IITerminated

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

BioMerieux SA

Under certain conditions, there is a risk for a false negative result.

September 2, 2021 · DeviceView details →

Class II

Terminated

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

Flower Orthopedics Corporation

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

September 1, 2021 · DeviceView details →

Class IITerminated

Thoraguard Chest Tube Kit, 20 Fr

Centese Inc.

An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

August 31, 2021 · DeviceView details →

Class IITerminated

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

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

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

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

SOMATOM Force with software syngo.CT VB20 Model #10742326

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

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

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

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

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

SOMATOM Drive with software syngo.CT VB20 Model #10431700

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

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 →

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