All Recalls

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

Product lacks 510(k) clearance.

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Product lacks 510(k) clearance.

A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Due to incomplete seals in the pouch which provide the sterile barrier.

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.