HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilt
FDA device recall Z-1185-2012 · posted 2012-03-07 · Terminated
Recall details
- Recalling firm
- Hamilton Medical Inc
- Reason for recall
- Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
- Action taken
- Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 456 devices in US.
- Distribution
- (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
- Date initiated
- 2012-02-06
- Date posted
- 2012-03-07
- Date terminated
- 2013-10-23
- Location
- Reno, NV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAMILTON-G5 (K103803) | Hamilton Medical AG | 2011-11-23 |