Medical equipment, implants, and diagnostic devices
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
Maquet Medical Systems USA
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet Medical Systems USA
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Maquet Medical Systems USA
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Cytrellis Biosystems
Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.
Maquet Medical Systems USA
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet Medical Systems USA
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Maquet Medical Systems USA
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Siemens Medical Solutions USA
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Olympus Corporation of the Americas
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Ortho-Clinical Diagnostics
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Olympus Corporation of the Americas
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Windstone Medical Packaging
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Siemens Healthcare Diagnostics
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
PHILIPS HEADQUARTERS CAMBRIDGE
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required