Recalls:
Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable
The recalled remote alarm cable may negatively affect Newport HT50 ventilators manufactured prior to 2007. Affected units may shutdown unexpectedly. ...
Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients
The doors and drawers may inadvertently open while the bassinet is in motion and the product may be difficult to maneuver due to its swivel caster configuration. If either of these events were to occur, there is the potential for injury to the patient, including death and...
CareFusion Cortical Stimulator Control Unit: Class I Recall - Software Malfunction and Short Circuit
The device's software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. Both of these issues may result in...
Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries
While turned on, the brush head of the Spinbrush has either 'popped off' or broken off in the user's mouth or near the face, causing cuts, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes. When the unexpected release...
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
An internal manufacturing defect was discovered which indicated that, in certain lots of the 7600 Bubble Humidifiers, the humidifier lids failed to pop off at the intended pressure. This may cause the humidifier to leak. A humidifier leak will potentially interrupt the...
Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective
FDA notified healthcare professionals about the illegal sale of hand-held dental X-ray units that have not been reviewed by the FDA. The FDA is aware of hand-held dental X-ray units being sold online by manufacturers outside the U.S. and directly shipped to customers in...
Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes - Inadvertent Dislodgment - Class I Recall
Some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes. If excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or…
Safety Information:
Radiography Resources for Pediatric Patients
Educational materials and a safety checklist for using plain film radiography on pediatric patients...
Highlighted Reports
This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives…
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