Diagnostic Equipment

Products were held at improper storage temperature

Sterility of device is not assured

It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d

Products were held at improper storage temperature

The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

Sterility of device is not assured

Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.

GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.

Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis

It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi

A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended

The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.

The firm found that the top cover of the mattresses were delaminating.

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.