Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: ca
FDA device recall Z-1928-2011 · posted 2011-04-08 · Terminated
Recall details
- Recalling firm
- Hamilton Medical Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 97 units
- Distribution
- Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
- Date initiated
- 2011-02-16
- Date posted
- 2011-04-08
- Date terminated
- 2012-03-21
- Location
- Reno, NV
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO HAMILTON-G5 (K081521) | Hamilton Medical AG | 2008-09-25 |