Recall Z-1928-2011 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical Inc
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
| Date | Apr 8, 2011 (initiated Feb 16, 2011) |
| Status | Terminated |
| Reason | The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator. |
| Root cause | Software design |
| Action | A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215. |
| Quantity | 97 units |
| Distribution | Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081521 | MODIFICATION TO HAMILTON-G5 Hamilton Medical AG, Sep 25, 2008 |