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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.