Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Perkin Elmer Life Sciences
Class I - Dangerous
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Class I - Dangerous
May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
Class I - Dangerous
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
Siemens Healthcare Diagnostics
Class I - Dangerous
ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.
Class I - Dangerous
Incorrect tubing.
Class I - Dangerous
In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.
Class I - Dangerous
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Class I - Dangerous
Images may be missing when a system parameter MapRoute is set to a value greater than 1.
Class I - Dangerous
This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.
Class I - Dangerous
Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
Class I - Dangerous
The company has determined the sterility cannot be assured for the affected lot.
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Olympus Corporation of the Americas
Class I - Dangerous
Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results