Other Medical Devices

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment

As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

Distributed VTM outside of VTM Guidance and without clearance.

Distributed VTM outside of VTM Guidance and without clearance.

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Product found to not comply to Class 1 Laser safety requirement.

The device was marketed and sold in the US without FDA clearance.

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

A potential for dual-configured beds to separate or slip away from one another.

There is the potential that during implant deployment, the device may not properly deliver a implant.

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

stability failure

A potential for dual-configured beds to separate or slip away from one another.

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.