Medical Devices Recalls

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Users were identifying autofill failure conditions on the devices causing pump stops.

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Ground cable installed incorrectly.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Due to manufacturing issue, panels may result in false negative results.

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.