Medical device recalls

Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

Incorrect IOL diopter

The bracket torque was mislabeled on the packaging.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

There is potential for the plastic optical tip to become detached from the metal shaft.

Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.