Medical device recalls

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Failed stability specifications for reagent kits that may result in false negative test results.

Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

The boxes used by the shipper were not validated for use during transport.

There is potential for multiple issues due to a manufacturing nonconformity.

individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running