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Displaying 1 - 11 of 11 items.
NCB Screw 5.0 L=38
Zimmer GmbH is conducting a medical device field safety corrective action (removal) for one lot of the NCB femoral screws. The product in scope is part of a mix-up with a NCB humeral screw that differs in dimensions and therefore it has been decided to…
RecallHealth product recall | 2022-06-27
Merlin Patient Care System - Programmer Software
Abbott is notifying customers of the potential for programmer software (Merlin pcs) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality,…
RecallHealth product recall | 2022-06-27
Defigard Touch7
In rare cases, when the device is switched on directly in defibrillator mode, cancellations of heart rhythm analysis after 30 seconds have been reported.
Recall start date: June 17, 2022
RecallHealth product recall | 2022-06-27
Aquac Uno H Reverse Osmosis System - Main Unit
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been…
RecallHealth product recall | 2022-06-27
Alinity and Architect A1C Reagent Kit
This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to…
RecallHealth product recall | 2022-06-20
Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/…
RecallHealth product recall | 2022-06-20
Epoc Blood Analysis Bgem Test Cards
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-…
RecallHealth product recall | 2022-06-20
F/O Laryngoscope
Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n…
RecallHealth product recall | 2022-06-20
Yelloport Elite Universal Seal
During the manufacturing process, there is a slight risk of the formation of a hole in the sterile packaging which typically forms near the pre-sealed area at the bottom of the sterile packaging of the Yelloport Elite Universal Seals.
Recall start…
RecallHealth product recall | 2022-06-13
Dimension Exl System - Cardiac Troponin-I (CTnI) Assay
Siemens Healthcare Diagnostics Inc. has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0…
RecallHealth product recall | 2022-06-13
Cobalt and Crome Mri Surescan
A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (…
RecallHealth product recall | 2022-06-03