All Recalls

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Reports of various packaging issues that may result in a breach of the sterile barrier.

Reports of various packaging issues that may result in a breach of the sterile barrier.

Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

False-positive MSI-H results generated by the Idylla MSI Test.

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers do not comply with the performance requirements of the STURDY Act.

A metal part inside the printer can dislodge, posing a risk of fire.

The door handle can stick and cause the door to unexpectedly open while the vehicle is moving and cause an unrestrained rider to be ejected from the vehicle or increase the risk of a crash, posing serious injury and crash hazards.

The smoke alarms can malfunction and fail to alert consumers of a fire, posing a risk of smoke inhalation or death. Smoke sensitivity tests performed on the alarms by CPSC found that one of the detectors that was tested failed to alert when exposed to pre-determined concentrations of smoke.