🏥 Medical Devices • 4,262 recalls
EXP Pharmaceutical Services
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
EXP Pharmaceutical Services
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
There is a potential the sling loops may not stay attached to the carry bar hooks.
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
Gardner Denver Thomas
Vacuum pump may not perform to specification.
Hitachi America, Ltd., Power Systems Division
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Gardner Denver Thomas
Vacuum pump may not perform to specification.
Gardner Denver Thomas
Vacuum pump may not perform to specification.
Devon Light Gloves contain splits or holes compromising the sterility
Incorrect thread form on the screw.
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Shipped to a single consignee prior to completion of final inspection.
The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.
Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
The software was failing to determine new patient locations if imaging is not enabled during treatment.