95,089 total recalls in our database
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
Siemens Medical Solutions USA
Software update that provides software and firmware bug-fixes to improve system performance
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Device can fail during operation.
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
Sterility of the outer surface of the container compromised due to packaging defect.
CYPRESS MEDICAL PRODUCTS
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Stryker Sustainability Solutions
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.
Firefly Medical
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
The devices wings may become partially detached from the EFx Shield during use.
Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.
Siemens Medical Solutions USA
Software update that provides software and firmware bug-fixes to improve system performance
Stryker Medical Division of Stryker
Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.
The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
Ulthera
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.