FDA Device Recalls

Class IITerminated

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

RAYSEARCH LABORATORIES AB

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

September 9, 2021 · DeviceView details →

ARCH Leg Positioning System

Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

Kit: Central Line Dres Change 20/Cs

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

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

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

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 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

Thoraguard Chest Tube Kit, 20 Fr

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

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

SOMATOM Force with software syngo.CT VB20 Model #10742326