Diagnostic Equipment

bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

A reagent contained within the product may return false negative results.

Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.

GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.

Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.

bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

Sterility of the product cannot be guaranteed.

When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.

Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize

GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.

Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.