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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland)

Class I - Dangerous

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Mar 6, 2015 Diagnostic Equipment Nationwide View Details →

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

Biomet

Class I - Dangerous

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Apr 16, 2015 Implants & Prosthetics Nationwide View Details →

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

HeartWare

Class I - Dangerous

HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

Apr 29, 2015 Other Medical Devices Nationwide View Details →

R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.

Smith & Nephew

Class I - Dangerous

The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.

May 6, 2015 Implants & Prosthetics Nationwide View Details →

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

Smiths Medical Asd

Class I - Dangerous

Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

May 4, 2015 Other Medical Devices View Details →

Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland)

Class I - Dangerous

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Mar 6, 2015 Diagnostic Equipment Nationwide View Details →

Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland)

Class I - Dangerous

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Mar 6, 2015 Diagnostic Equipment Nationwide View Details →