Diagnostic Equipment

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.

Incorrect tubing.

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.

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.

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

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.

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.

The company has determined the sterility cannot be assured for the affected lot.

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

CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.

Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.