The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
🏥
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Misbranded: Incorrect etching on the device.
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Class I - Dangerous
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Class I - Dangerous
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.
Class I - Dangerous
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
Class I - Dangerous
Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
Class I - Dangerous
Potential sterility deficiency.
The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Smith & Nephew
Class I - Dangerous
Sterility compromised due to breach in sterile packaging
Class I - Dangerous
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.