Other Medical Devices

Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Failure to submit a premarket submission and gain approval of a medical device.

The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m

Failure to submit a premarket submission and gain approval of a medical device.

Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Imprecision with certain lots

The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.

An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.

Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho

The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha

Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.