Medical Devices Recalls

Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Hazard: May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Hazard: Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

Hazard: Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.

Hazard: GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

Hazard: GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

Hazard: Specific lots of product have been manufactured with nonconforming raw materials.

Hazard: Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.

Hazard: There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

Hazard: CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.

Hazard: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Hazard: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Hazard: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.

Hazard: Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

Hazard: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

Hazard: Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

Hazard: Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

Hazard: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Hazard: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Hazard: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.

Hazard: Contamination with foreign substance matter

Hazard: Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Hazard: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.

Hazard: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.