Medical equipment, implants, and diagnostic devices
Ortho-Clinical Diagnostics
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Certain lots containing undersized dilator.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Philips Respironics
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Abbott Molecular
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Biosense Webster
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Philips Respironics
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Aesculap Implant Systems
Potential for the incorrect screw to be included in the package.
Oculus Optikgeraete GMBH
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Procedure packs contained a recalled product.
Siemens Medical Solutions USA
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Abbott Laboratories
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
There are 7 reported software anomalies that may affect use of the device.
OXFORD IMMUNOTEC
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.