Other Medical Devices

An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

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.

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.

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.

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

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.

Product lacks 510(k) clearance.